Research & Development / Design Engineer Position Summary An exciting opportunity exists for an experienced R&D / Design Engineer to contribute to the design, development, and continuous improvement of innovative medical products. The successful candidate will play a key role in product development — from concept through to prototype, testing, and final implementation — working closely with cross-functional teams to deliver high-quality, compliant medical device solutions. Key Responsibilities <ul><li>Design and develop new medical products from concept to production.</li><li>Evaluate product and process performance, maintaining all required documentation and records.</li><li>Select appropriate raw materials, components, and suppliers in line with project needs.</li><li>Fabricate prototypes and conduct testing to verify design performance.</li><li>Collaborate and communicate effectively with Project Managers and customers on project progress.</li><li>Serve as a technical resource and mentor for less experienced colleagues.</li><li>Drive continuous improvement in products and processes.</li><li>Perform other duties as required by project or management needs.</li><li>Comply with all relevant Health & Safety requirements.</li></ul>Candidate Profile Ideal candidates will have most or all of the following qualifications and experience: <ul><li>Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline (essential).</li><li>5+ years of experience in a similar R&D or Design Engineering role (essential).</li><li>Experience working in a medical device or regulated environment (advantageous but not essential).</li><li>Strong ability to manage multiple projects and adapt to changing priorities.</li><li>Highly motivated, self-starting, and able to work both independently and as part of a team.</li><li>Excellent problem-solving and analytical skills.</li><li>Demonstrated ownership and accountability for tasks through to completion.</li><li>Proficiency in a high-end CAD system, ideally SolidWorks.</li><li>Hands-on approach to design, prototyping, and fabrication.</li><li>Understanding of and ability to work to international medical device regulations.</li></ul>

R&D Design Engineer

Business Project Manager (“BPM”) Position Summary The Senior-level Business Project Manager will lead a cross-functional business team in launching new F4 supply chain and manufacturing IT systems. The Business Project Manager (“Business BPM”) acts as the “voice of the business” on activities that drive collaborative IT project work efforts from start to finish. This role serves as the key liaison between participating business teams, the IT Project Manager, and various IT technical and testing teams — working collaboratively to organize, plan, control, execute, test, and release business-proposed IT solutions and systems, while managing post-release activities. This is an individual contributor position that partners closely with the IT Project Manager and operates with minimal supervision. The BPM helps identify business needs, coordinate requirements gathering, track progress, manage business risks, and foster collaboration to achieve project goals. The role ensures F4 projects are completed on time, within budget, and in alignment with agreed objectives. The successful candidate will have a proven track record in managing high-impact programs, along with strong organizational, communication, leadership, and influencing skills. They will work with F4 leaders and cross-functional teams across Distribution/Warehousing, Quality Control, Supply Planning, IT, Regulatory, Operations, Tax, Finance, and Manufacturing. Essential Duties and Responsibilities <ul><li>Partner with IT Project Managers and multiple external resources to build, maintain, and execute the F4 business plan that aligns with global operations objectives.</li><li>Ensure all project objectives are achieved on time and within budget, while adhering to corporate policies, Regulatory standards, and Quality Management System requirements.</li><li>Lead F4 project launches and establish development, testing, and production readiness by coordinating with internal, external, and global teams.</li><li>Drive actionable items across departments and ensure deliverables meet quality standards (e.g., low defect rates).</li><li>Develop program documentation, including program charters, integrated roadmaps, and execution plans.</li><li>Plan and coordinate training and communication programs with relevant teams.</li><li>Act as the primary point of contact for stakeholders and business partners, providing regular progress updates and facilitating effective communication between teams.</li><li>Identify and resolve project issues, adapting plans to accommodate change.</li><li>Establish project governance frameworks to support decision-making and manage critical risks.</li><li>Thrive in a fast-paced, dynamic environment while managing multiple tasks and timelines.</li><li>Perform other related duties as assigned.</li></ul>Required Qualifications <ul><li>Strong business maturity and emotional intelligence.</li><li>Ability to work onsite at the Ireland facility in Athenry.</li><li>Excellent communication and facilitation skills for engaging teams and executive leaders.</li><li>Skilled in applying diplomacy and professionalism to overcome challenges and maintain project momentum.</li><li>Highly collaborative, team-oriented, and capable of resolving conflict constructively.</li><li>Experience in Logistics, Supply Chain, and/or Manufacturing Operations.</li><li>Proficiency with project management tools such as Smartsheet, Microsoft Project, or Atlassian tools (Confluence, Jira).</li><li>Demonstrated ability to manage complex projects effectively.</li></ul>Preferred Qualifications <ul><li>Certifications in program/project management, change management, or Lean Six Sigma (e.g., PMP, Six Sigma Green/Yellow Belt).</li><li>Experience working within a Medical Device or Healthcare industry Quality Management System.</li><li>Familiarity with Oracle Materials Management modules, Voice Technology, Warehouse Management Systems, Transportation Management Systems, or SharePoint.</li><li>Additional Project Management certification(s).</li></ul>

Business Project Manager

Our client, a leading biopharmaceutical company, is seeking a Documentation Specialist to support manufacturing operations and ensure the highest standards of quality, compliance, and efficiency. Key Responsibilities: <ul><li>Coordinate review, approval, and control of all manufacturing documentation (MBRs, SOPs, logbooks, labels).</li><li>Ensure timely document progression in line with cGMP and site procedures.</li><li>Support NPI, tech transfer, and routine manufacturing documentation readiness.</li><li>Maintain strong compliance with GDP and GMP standards.</li><li>Track key performance metrics and support continuous improvement initiatives.</li><li>Act as a key contact for manufacturing and provide SME support on documentation processes.</li></ul> Requirements: <ul><li>Bachelor’s Degree or equivalent preferential, preferably in a Science or related field</li><li>1+ years’ experience in a regulated manufacturing environment.</li><li>Proven experience in document control and records management within GMP settings.</li><li>Proficiency in Microsoft Word, Excel, PowerPoint, and electronic document management systems.</li><li>Strong attention to detail and ability to meet tight deadlines.</li></ul> For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Documentation Specialist

Project Lead – Shop Floor Integration Layer (SIL) Deployment About the Role We are seeking a Project Lead / Project Engineer to support the rollout of a Shop Floor Integration Layer (SIL) program using Ignition SCADA/MES across multiple manufacturing sites. This initiative is central to driving digital manufacturing maturity, enabling real-time data flow, automationand efficiency. This role is ideal for a hands-on project professional who can coordinate multi-site deployments, bridge business needs with technical execution and drive progress while ensuring alignment to global standards. Unlike a traditional project manager, this role stays closely connected to site-level realities, advancing both implementation and change management. The position is contract-based, with a strong preference for candidates based in the EU for time zone alignment and proximity to key sites. Key Responsibilities<ul><li>Develop and maintain detailed project plans for each site, including milestones, resources, and Ignition deployment steps.</li><li>Work with local site teams to adapt plans to their unique requirements and challenges.</li><li>Track progress daily/weekly, using collaboration and reporting tools to ensure timelines are met.</li><li>Provide clear, structured updates on progress, risks, and key metrics to global stakeholders.</li><li>Manage scope changes, assessing impacts on schedules and system integrity.</li><li>Identify and escalate technical or integration issues quickly to avoid delays.</li><li>Coordinate support needs, including subject matter experts, resources, or funding.</li><li>Create and document standards for shop floor integration to drive consistency across sites.</li><li>Gather requirements through workshops, surveys, and consultations to inform deployment.</li><li>Drive execution forward with a practical, problem-solving approach grounded in site realities.</li><li>Travel up to 50% across EU and international sites to support workshops, assessments, and go-lives.</li></ul> Qualifications & Experience<ul><li>5+ years of experience in project engineering or project management.</li><li>Background in industrial automation (SCADA/MES, shop floor integration, manufacturing IT/OT).</li><li>Experience in pharma, life sciences, or regulated manufacturing environments is a plus.</li><li>Strong working knowledge of Ignition platform (SCADA/MES) or similar automation systems.</li><li>Proven ability to manage complex, multi-site deployments.</li><li>Excellent communication, coordination, and organizational skills.</li><li>Strong problem-solving mindset with the ability to balance global standards and local needs.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Project Lead

C&Q Engineer – Cork Our client, a leading pharmaceutical organization, is seeking a Commissioning & Qualification (C&Q) Engineer to join their dynamic team in Cork. This is an exciting opportunity to work on state-of-the-art pharmaceutical systems and make a real impact in a fast-paced GMP environment. Role Overview: As a C&Q Engineer, you will be responsible for: <ul><li>Generating, executing, and approving Qualification documents for Direct Impact Systems (Facility, Utility, Equipment).</li><li>Creating Commissioning Test documents for Non-Direct Systems.</li><li>Ensuring all systems meet cGMP and cGDP standards and project timelines.</li></ul> What We’re Looking For: <ul><li>BS Degree in Engineering, Science, or a technical discipline.</li><li>3+ years of Commissioning & Qualification experience, preferably in OSD or pharmaceutical settings.</li><li>Experience with clean utility tie-ins, sanitary equipment, hygienic piping, process instrumentation, and controls.</li><li>Knowledge of risk-based commissioning and qualification approaches.</li><li>Familiarity with project management tools is a plus.</li><li>Strong technical writing skills and experience working in a GMP-regulated environment.</li><li>Ability to work independently, demonstrate teamwork, and adapt to project demands.</li></ul> Systems Experience: <ul><li>Facility/Qualification systems</li><li>Dispensing equipment (down flow booths, matcom stations, PTS powder systems)</li><li>Tumble mixer equipment, including CIP skid</li><li>Utilities such as compressed air systems. </li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

C&Q Engineer

Head of Manufacturing We are seeking an ambitious and driven professional to lead manufacturing operations in a fast-paced environment. This is a unique opportunity to play a key role in driving operational efficiency, quality, and innovation across manufacturing services that support final assembly operations. Key Responsibilities<ul><li>Production & Capacity Planning – Manage production workflows and resources to meet output targets. Lead molding and surface mount assembly operations, delivering core plant KPIs and implementing strategic initiatives.</li><li>Quality & Cost Control – Oversee quality processes, monitoring defects, yields, and PPM levels. Manage budgets, ensuring labor, material, and overhead costs remain on target.</li><li>Process Improvement – Drive continuous improvement in processes, equipment, and workflows to increase efficiency and reduce waste.</li><li>Team Leadership – Lead and develop a high-performing technical team, fostering a positive and collaborative work culture.</li><li>Health & Safety – Implement safety protocols and ensure compliance to maintain a safe working environment.</li><li>Sustainability & Technology – Lead plant-wide sustainability initiatives to achieve net carbon neutrality by 2030, ensure ISO 50001 compliance, and integrate new technologies and automation to boost efficiency.</li></ul>Candidate Profile<ul><li>7+ years’ operational experience, with technical management responsibility (manufacturing preferred).</li><li>Degree in Mechanical, Production, or related Engineering field (or equivalent).</li><li>Proven leadership in managing technical teams.</li><li>Strong strategic, problem-solving, and decision-making skills.</li><li>Excellent communication and interpersonal abilities.</li></ul>

Head of manufacturing

The Role: Our client, a leader in the pharmaceutical manufacturing sector, is seeking a Engineering Technician to join their high-performing team. This role is on a contract basis and follows a 2 cycle shift pattern (Day/Evenings, Monday-Friday). This role is critical in supporting engineering operations and ensuring equipment reliability in a regulated GMP environment. You will play a key role in maintaining and improving manufacturing equipment, supporting new equipment commissioning, and driving performance through proactive maintenance strategies. Responsibilities: <ul><li>Collaborate with cross-functional teams to support pharmaceutical operations in compliance with all safety, regulatory, and quality standards.</li><li>Actively contribute during design and process reviews to ensure reliability by design is incorporated before equipment installation.</li><li>Develop, own, and approve preventative and predictive maintenance (PM/pDM) procedures for new equipment using Maximo CMMS.</li><li>Ensure commissioning and critical spare parts are cataloged and managed efficiently within Maximo.</li><li>Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and equipment commissioning and qualification.</li><li>Review and approve engineering documentation including PFDs, specifications, P&IDs, and layout drawings.</li><li>Support execution of commissioning, qualification, and validation protocols to meet project deadlines.</li><li>Perform and document instrument calibrations and ensure schedules are maintained.</li><li>Drive the Predictive Maintenance Program, managing condition monitoring contracts and implementing improvement actions.</li><li>Lead troubleshooting and root cause analysis of complex equipment issues, including instrumentation and PLC systems.</li><li>Ensure high performance and reliability of manufacturing and utility equipment through daily maintenance activities.</li><li>Liaise with internal stakeholders and external contractors to manage installation, maintenance, and system upgrades.</li><li>Support regulatory inspections and corporate audits by maintaining compliance and documentation standards.</li><li>Supervise and manage external contractors as required.</li></ul> Qualifications & Experience: <ul><li>Minimum: Trade Certification or Engineering Qualification at Certificate Level.</li><li>Preferred: Diploma or Degree in Engineering (Mechanical, Electrical, or related discipline).</li><li>Experience:</li><li>Minimum 3 years in a regulated manufacturing environment (Pharma, Biologics, or Medical Device).</li><li>Strong knowledge of GMP practices and regulatory compliance.</li><li>Proven ability to troubleshoot instrumentation and PLC systems.</li><li>Familiarity with Maximo or equivalent CMMS.</li><li>Demonstrated experience with preventative and predictive maintenance programs.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Engineering Technician 

We are seeking an experienced Product Quality Engineer to join our client’s growing team. This is a pivotal role working across R&D, Quality, Production, and Test Engineering, ensuring that both hardware and software product designs meet the highest standards of quality, reliability, and compliance. The ideal candidate will have strong technical expertise, hands-on experience with product development, and the ability to influence design processes from concept through to launch and beyond. Responsibilities <ul><li>Collaborate with R&D teams to assess and influence product designs for quality, reliability, and compliance.</li><li>Review schematics, PCB layouts, and hardware specifications to identify potential design risks.</li><li>Lead design risk assessments (DFMEA) and support root cause analysis activities.</li><li>Support validation and verification for new product introductions.</li><li>Partner with Purchasing and R&D teams to qualify new vendors and parts.</li><li>Perform statistical analysis and reporting of test data.</li><li>Support hardware and software testing from a quality perspective.</li><li>Provide technical support to Production, Test, and Process Quality teams to resolve product-related issues.</li><li>Act as a technical quality representative in design reviews and development meetings.</li><li>Support audits and inspections related to design controls.</li><li>Drive continuous improvement in design processes and quality metrics.</li></ul> Requirements: <ul><li>Bachelor’s degree in Electronic, Electrical, Software Engineering, or related field.</li><li>5+ years’ experience in a Quality or R&D role within a regulated industry (medical devices, aerospace, automotive, or life safety).</li><li>Strong understanding of product development lifecycle and design controls.</li><li>Experience with hardware/software integration and testing.</li><li>Familiarity with ISO 9001 or similar quality management systems.</li><li>Ability to interpret electronic schematics, circuit designs, and technical specifications.</li><li>Skilled in FMEA, risk management, and root cause analysis.</li><li>Knowledge of embedded systems, firmware, or software development.</li><li>Strong communication and cross-functional collaboration skills.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Product Quality Engineer

We are seeking a Project Engineer to join our client’s Engineering & Technology team, leading critical projects across new product introductions, aseptic processing, automation, and process improvements. This is an exciting opportunity to work on cutting-edge projects and contribute directly to improving patient outcomes, while developing your career in a fast-paced and innovative environment. Responsibilities:  <ul><li>Lead cross-functional teams to deliver new processing equipment and facility upgrades safely, on time, and on budget.</li><li>Draft User Requirement Specifications (URS) and manage vendor selection and evaluations.</li><li>Drive project management activities including RCEs, design reviews, FATs, commissioning, and qualification.</li><li>Oversee installation, documentation, training, and handover of new systems.</li><li>Support process improvement and cost reduction initiatives.</li><li>Collaborate closely with stakeholders in Quality, Operations, Technology, Validation, and EHS.</li></ul> Requirements:  <ul><li>Third-level qualification in Engineering or related discipline.</li><li>2–5 years’ experience in Biologics, Pharmaceuticals, or Medical Devices.</li><li>Proven project management track record.</li><li>Strong technical background with excellent problem-solving skills.</li><li>Confident communicator with the ability to lead teams and influence stakeholders.</li><li>Adaptable, results-driven, and collaborative mindset.</li><li>Willingness to travel for design reviews, inspections, and FATs.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Project Engineer

Maintenance Technician - Fitter Department: Job describtion: Duties to include; Preventative maintenance, fabrication and repair on machines and equipment; as well as responding to emergency machine break downs throughout the plant; Involvement with new design, installation and movements of existing machines; Overhaul and repair of machines and equipment. Ensuring machines and equipment on site are safe, working efficiently and fit for purposes. Dayshift working initially but must be prepared to work shifts, work overtime and respond to call outs as required in line with the remit of the post. Key areas of responsibility: <ul><li>Ensure all machines are safe and fit for purpose</li><li>Actively practice and promote safe working practices</li><li>Fault finding, testing, and the repair or adjustment of existing fittings, fixtures and parts</li><li>Where a detailed specification is not provided, work in consultation with stake holders to develop and implement the most effective solution..</li><li>Undertake repairs and servicing to the highest standard in accordance with work requests and pre-determined specifications</li><li>Overhaul, upkeep and repair of all plant machines including;</li></ul>        o Heading and forming equipment         o Multi spindle turning machines         o Heat treatment furnace lines and associated support equipment         o Plating line o Automatic inspection equipment         o Packaging equipment • Installation of new machines and equipment <ul><li>Design, promote and carry out Preventative Maintenance</li><li>Review and advise on engineering requirements and drawings • Supporting production in process improvements</li><li>Support purchasing on a technical level with vendors • Work with and coordinate contractors</li><li>Effective communication – keeping management and relevant parties aware and seeking advice and assistance when required.</li><li>Any other duty as may be required commensurate with the grading of the post and the skill of the post holder.</li><li>Documentation of work carried out</li><li>Ensure compliance with environmental, health, and safety standards by actively promoting safe work practices and participating in regular safety training.</li></ul>Qualifications: <ul><li>Qualification in tool making or fitting.</li><li>Good organizational skills • Self motivated individual with good troubleshooting skills.</li><li>Able to communicate, both in writing and verbally, with internal and external people.</li><li>Computer literate including Email and Microsoft Office – Word, Excel, Access, Power point General:</li><li>To contribute to company objectives and values</li><li>To adhere to Company Rules / Health and Safety / Environmental Standards and Practices</li><li>Ensure that they continuously look for improvements to the service and for effective good practice within their role.</li><li>Responsibility to support and train other team members in the skills of the job</li><li>Requirement to work both as part of a team and unsupervised</li><li>Participate when requested in improvement programs such as FMEAs, 5S and Lean </li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Maintenance Technician - Fitter

Project Manager – R&D Location: Shannon, Co. Clare, Ireland Department: Engineering R&D Reports To: Program Manager R&D Job Type: Full-Time, Permanent, Onsite About the Role We are seeking a skilled and proactive Project Manager to lead cross-functional teams in delivering complex electronic products from concept through to production. You will be responsible for managing the full project lifecycle, ensuring delivery on time, within scope, and to the highest quality standards. This role involves coordinating engineering, quality, manufacturing, and supply chain functions, while applying structured project management practices and the company’s gate review process. Key Responsibilities <ul><li>Lead cross-functional project teams across engineering, quality, manufacturing, and supply chain.</li><li>Plan, schedule, and manage risks, resources, budgets, and deliverables.</li><li>Enforce project governance through the stage-gate process.</li><li>Provide clear progress updates to senior management and stakeholders.</li><li>Coordinate between engineering and manufacturing partners (including NPI and test engineering).</li><li>Manage scope, schedule, and cost changes through structured change control.</li><li>Ensure compliance with regulatory and safety standards.</li><li>Drive continuous improvement of project delivery processes and tools.</li></ul>Qualifications & Experience Minimum 5 years’ experience in project management, ideally in electronics product development. Bachelor’s degree (or higher) in Engineering, Science, or Technology. Formal project management qualification (e.g., PMP, Prince2) – PMP preferred. Familiarity with Agile/Scrum methodologies is desirable. Proven track record in structured project management for cross-functional product development. Strong knowledge of: <ul><li>Electronic hardware design & development</li><li>Embedded firmware/software</li><li>Mechanical product design</li><li>Cloud communication protocols & IoT platforms</li><li>Laboratory validation, testing, and certification</li></ul>Desirable Skills <ul><li>Excellent leadership, communication, and interpersonal skills</li><li>Ability to manage multiple projects and competing priorities</li><li>Strong problem-solving and analytical mindset</li><li>Experience in regulated industries (life safety, medical, industrial controls)</li><li>Proficiency with project management tools (MS Project, Monday.com, Teamwork.com, Jira, Confluence, etc.)</li><li>Experience with product lifecycle management (PLM) systems</li></ul>

Project Manager - R&D

Production Lead Purpose To oversee production operations, ensuring equipment, processes, and teams deliver safely, efficiently, and to the highest quality standards. Key Responsibilities <ul><li>Manage day-to-day production activities including scheduling, equipment care, and process improvement.</li><li>Coordinate with management to meet delivery schedules and inventory targets.</li><li>Ensure efficient use of resources (materials, equipment, people).</li><li>Monitor and improve processes to maintain quality and reduce downtime.</li><li>Lead and support the development, training, and performance of the production team.</li><li>Maintain compliance with policies, procedures, and quality standards.</li><li>Drive continuous improvement, preventative maintenance, and safe working practices.</li><li>Promote knowledge sharing, best practices, and employee engagement.</li></ul>Key Performance Indicators <ul><li>Achievement of output and delivery targets</li><li>Product quality and conformance</li><li>Equipment uptime and efficiency</li><li>Scrap/waste reduction</li><li>Team development and engagement</li><li>Budget and cost control</li></ul>Knowledge, Skills & Experience <ul><li>Degree in Engineering (preferably in Injection Moulding/Polymers) desirable.</li><li>Strong knowledge of production processes and equipment.</li><li>5+ years’ experience in a manufacturing/operations role.</li><li>Proven leadership and people management skills.</li><li>Understanding of quality systems, preventative maintenance, and continuous improvement.</li><li>Strong communication skills, written and verbal.</li></ul>Competencies <ul><li>Leadership and team development</li><li>Problem-solving and decision-making</li><li>Continuous improvement mindset</li><li>Organisational and planning ability</li><li>Safety and quality focus</li></ul>Additional Information This role description provides an overview of responsibilities and may evolve with business needs. Training and development opportunities will be provided.

Production Lead

Product Regulatory Manager  We are seeking a Product Regulatory Manager to lead the regulatory strategy for a leading international manufacturer of safety-critical electronic products. This is a pivotal role, ensuring products meet global standards and approvals, while driving compliance across the full product lifecycle. The Role As Product Regulatory Manager, you will: Responsibilities:  <ul><li>Define, implement, and maintain a comprehensive global regulatory compliance strategy.</li><li>Monitor and interpret emerging international standards and directives (e.g., CPR, RED, LVD, EMC, RoHS, WEEE, UKCA, UL, CE, BSI, VdS).</li><li>Guide R&D, Quality, Manufacturing, Sales, and Marketing teams on compliance throughout the product lifecycle.</li><li>Manage all product approvals and certifications for new and existing products.</li><li>Act as the primary contact for Notified Bodies, regulatory authorities, and certification agencies.</li><li>Lead regulatory audits, inspections, and assessments.</li><li>Maintain robust documentation and ensure compliance is embedded within the company’s Quality Management System (ISO 9001 or equivalent).</li><li>Support post-market surveillance, compliance monitoring, and recall processes if required.</li></ul> Requirements:  <ul><li>A bachelor’s degree in Engineering, Science, Law, or a related technical field.</li><li>At least 3 years of experience in a dedicated regulatory role within manufacturing (electronics or regulated consumer goods preferred).</li><li>In-depth knowledge of international product regulatory frameworks and standards (CPR, RED, LVD, EMC, RoHS, WEEE, REACH, UKCA, UL, BSI, VdS).</li><li>Hands-on experience managing complex product approvals and working with Notified Bodies.</li><li>Strong understanding of Quality Management Systems (ISO 9001 or similar).</li><li>Excellent communication skills, able to simplify complex compliance requirements for a range of stakeholders.</li><li>Strong organisation, attention to detail, and project management skills.</li><li>A proactive and collaborative mindset, with the ability to work independently.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Product Regulatory Manager

Compliance Manager An exciting opportunity has arisen for an experienced Compliance Manager to join a leading organisation within the manufacturing and electronics sector. This is a pivotal leadership role, responsible for shaping and driving compliance strategy to ensure the highest standards of quality, safety and environmental responsibility are met across the business. You will oversee QEHS management systems, manage global product regulatory approvals and ensure readiness for audits, while fostering a culture of continual improvement. Key Responsibilities <ul><li>Health & Safety (ISO 45001): Manage and improve the Health & Safety Management System, ensuring compliance with legislation, risk assessments and safety-first culture.</li><li>Environmental Management (ISO 14001): Oversee certification, assess environmental risks and implement sustainability strategies aligned with regulations and company goals.</li><li>Quality Management (ISO 9001): Maintain and develop the QMS, manage audits, ensure document control and oversee calibration programmes.</li><li>Product Regulatory Approvals: Lead and coordinate global product approvals (CE, UKCA, UL, EN standards), liaising with test labs, notified bodies and regulatory authorities.</li><li>Leadership & Governance: Develop compliance frameworks, engage with auditors and certification bodies and report to senior management on compliance risks and performance.</li></ul> Skills & Experience <ul><li>Degree in Engineering, Quality, Environmental Science, Occupational Health & Safety or a related discipline.</li><li>Minimum 5 years’ experience in compliance, quality or regulatory affairs (manufacturing/electronics preferred).</li><li>Proven track record managing ISO certification programmes.</li><li>Knowledge of product safety standards (EN 14604, EN 50291, UL 217, etc.) is highly desirable.</li><li>Familiarity with EU, UK and global regulatory frameworks.</li><li>Strong leadership, communication and influencing skills.</li><li>Excellent organisational and project management capabilities.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Compliance Manager

Production Manager About the Company A global leader in life science and diagnostics, offering a diverse portfolio of businesses that combine the resources of a large company with the agility of a small business. The organisation is committed to providing top-notch customer care and innovative solutions across the industry, ensuring customers receive high-quality products and exceptional support tailored to their research needs. About the Role An experienced and motivated Production Manager is required to join the team in Shannon. Reporting to the Operations Director and working closely with the Senior Leadership Team, this full-time, on-site role is responsible for leading and managing the production department to ensure products are manufactured safely, efficiently, and in line with customer demand. The successful candidate will oversee multiple production cells, resource planning, quality inspection, and compliance activities, while also driving continuous improvement initiatives across the department. This is an excellent opportunity for a strong leader with a background in production and lean manufacturing, who thrives in a fast-paced environment and enjoys developing people, processes, and systems to enhance organisational effectiveness. Key Responsibilities <ul><li>Manage all production cells (Small Batch, Large Batch, Solvents, Tank Farm, Organics, Metals, TOC) to meet departmental and overall business targets.</li><li>Develop and manage the production schedule, ensuring accurate forward planning and strict adherence to ATP commitments.</li><li>Oversee the Quality Inspection team and Production QC Inspector, ensuring data is accurately collected, collated, and reported in line with the Quality Management System.</li><li>Collaborate with the Quality team to ensure robust inspection regimes and minimise customer complaints.</li><li>Drive efficiency and cost-reduction initiatives by implementing lean practices, automation, technology enhancements, and process improvement projects, in partnership with the Lean Specialist.</li><li>Ensure compliance with ISO17034 requirements for the production of certified reference materials, coordinating planning and execution with Cell Leads.</li><li>Lead resource planning across human, material, and equipment requirements to ensure production readiness and sustainability.</li><li>Maintain strict adherence to company policies, procedures, housekeeping, and health & safety regulations.</li><li>Manage and develop direct reports, including coaching, motivating, and ensuring adequate training to achieve individual and team goals.</li><li>Actively contribute to or lead cross-functional projects as required.</li><li>Play a significant role in the strategic planning of the business to drive organisational effectiveness.</li><li>Undertake any additional responsibilities as outlined by the Operations Director.</li></ul>Qualifications & Experience <ul><li>Minimum of 5 years’ experience in a senior role within a production facility.</li><li>Strong understanding of production processes, lean manufacturing principles, and the laboratory supplies industry.</li><li>Bachelor’s degree in Science (BSc), preferably Chemistry.</li><li>Lean qualification desirable.</li></ul>Personal Attributes <ul><li>Excellent interpersonal and leadership skills with the ability to coach and develop teams.</li><li>Flexible, innovative thinker with a wide skill base and ability to multi-task effectively.</li><li>Strong team player who fosters collaboration and builds positive relationships across functions.</li><li>Results-driven with a focus on continuous improvement, efficiency, and quality.</li><li>Highly organised, proactive, and able to manage competing priorities in a fast-paced production environment.</li></ul>Additional Information <ul><li>This position is based on-site in Shannon.</li><li>Occasional travel may be required depending on business needs.</li><li>Applicants must be eligible to work in Ireland.</li></ul>

Production Manager

About the job Our client, a global leader in the manufacturing is seeking a proactive and motivated Health & Safety Officer to join their team in Ireland. The company is ISO9001 and AS9100 certified, committed to maintaining the highest standards of safety, quality and innovation. The Role This is an exciting opportunity for a Health & Safety professional who is passionate about driving a culture of safety and continuous improvement. Reporting to senior management, you will be responsible for implementing and maintaining effective health, safety and environmental policies while ensuring compliance with Irish and EU legislation. Key Responsibilities <ul><li>Develop, implement, and review HSE policies and procedures in line with legislation and best practices.</li><li>Act as a trusted advisor on health and safety matters to management and employees.</li><li>Engage with Safety Committees and Representatives to promote best practice and compliance.</li><li>Champion a positive and inclusive health & safety culture across the organisation.</li><li>Deliver HSE training (onboarding, compliance, updates, new requirements).</li><li>Conduct audits, inspections and risk assessments, ensuring corrective actions are followed through.</li><li>Lead incident/accident investigations, providing data-driven insights for prevention.</li><li>Oversee emergency planning, including evacuation drills and readiness checks.</li><li>Prepare and present safety reports and metrics to senior management.</li></ul> What we’re looking for <ul><li>Third-level qualification in Health & Safety (or recognised equivalent).</li><li>2–3 years’ experience as a Safety Officer (manufacturing experience an advantage, not essential).</li><li>Strong knowledge of Irish & EU health & safety legislation.</li><li>Experience in risk assessments, audits and training delivery.</li><li>Excellent communication skills with the ability to influence and engage at all levels.</li><li>Self-motivated, proactive and solutions-focused professional.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Health and Safety Officer

About the job:  Our client, a leading manufacturing organisation is seeking a Senior Treasury Analyst to join their team in Shannon. This is an exciting opportunity to play a key role in managing treasury operations, investment activities and risk management while contributing to decision-making that drives the Group’s success. Responsibilities: Treasury Management: <ul><li>Assist in managing liquidity, cash flow, and banking relationships.</li><li>Monitor and assist in forecasting cash requirements and operational funding needs.</li><li>Execute treasury transactions, including money market and foreign exchange activities.</li></ul> Investment Analysis & Reporting <ul><li>Prepare comprehensive liquidity and investment analysis and reporting.</li><li>Analyse financial data and trends to support decision-making processes.</li><li>Develop and maintain financial models for forecasting and budgeting.</li><li>Prepare regular and ad-hoc reports on treasury and investment activities.</li></ul> Risk Management & Compliance <ul><li>Identify and assess financial risks related to treasury and investment activities. • Monitor risk exposures against agreed limits and ensure ongoing compliance.</li><li>Implement agreed risk mitigation strategies and ensure compliance with company policies and regulatory requirements.</li><li>Support the continued development and implementation of appropriate policies, including in relation to liquidity, counterparties, concentration, interest rate risk and FX risks.</li><li>Support and contribute to best practice treasury control environment.</li><li>• Lead on KYC and other relevant compliance processes.</li></ul> Skills and Experience: <ul><li>Honours degree in Finance, Accounting, Economics, or related field.</li><li>Professional qualification (e.g., Accounting, Corporate Treasury) is an advantage or the willingness to pursue one.</li><li>3–5 years’ experience in treasury, investment management or financial analysis.</li><li>Proven experience in data analysis, financial modelling and treasury systems.</li><li>Strong knowledge of financial instruments, markets and risk management.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Treasury Analyst

Manufacturing Engineer Shannon, Co. Clare, Ireland We are seeking an experienced Manufacturing Engineer to join our growing team in Shannon, Co. Clare. This is a key role within a fast-paced, multi-national manufacturing environment where your ideas, problem-solving skills, and engineering expertise will directly influence production efficiency, product quality, and customer satisfaction. What You’ll Do <ul><li>Innovate & Improve – Design, plan, and refine manufacturing processes that are efficient, scalable, and easy to implement.</li><li>Prototype to Production – Manufacture and validate prototypes, then transition them into full production runs.</li><li>Drive Efficiency – Identify cost-saving opportunities, improve on-time delivery, and champion lean manufacturing practices.</li><li>Collaborate Globally – Work closely with customers, suppliers, and cross-functional teams to resolve challenges and deliver excellence.</li><li>Enhance Systems – Contribute to the development and implementation of a new ERP system.</li><li>Document & Deliver – Maintain accurate technical documentation and ensure processes meet quality and safety standards.</li><li>Support & Lead – Assist the engineering team, ensuring flexibility across multiple projects.</li></ul>What We’re Looking For <ul><li>Bachelor’s degree in Manufacturing, Mechanical, Industrial Engineering or related field.</li><li>2–5 years in a manufacturing or industrial engineering role.</li><li>Hands-on experience with process development, optimization, and improvement projects.</li><li>Proficiency in CAD tools (SolidWorks, AutoCAD).</li><li>Knowledge of Lean Six Sigma (Green Belt+ preferred).</li><li>Experience in ERP systems (implementation experience is a plus).</li><li>Familiarity with RCA, FMEA, CAPA, and other quality tools.</li><li>Strong communication skills, adaptability, and a continuous improvement mindset.</li></ul>

Manufacturing Engineer

Purchasing & Procurement Manager – Manufacturing We’re recruiting on behalf of our client, a rapidly growing manufacturer transitioning from SME to medium-sized enterprise. They are seeking a Purchasing & Procurement Manager to lead a team of three in a fast-paced, engineered-to-order environment. This is a newly created role reporting directly to the Procurement & Supply Chain Director, offering the opportunity to shape procurement strategy, enhance supplier performance, and implement best-in-class purchasing practices. Responisibilities:  <ul><li>Lead and develop a team of three buyers to ensure timely, cost-effective procurement.</li><li>Build and maintain strategic global supplier relationships across Europe, China, and the USA.</li><li>Drive department KPIs for on-time delivery, supplier performance, cost savings, and stock control.</li><li>Implement Supplier Managed Inventory (SMI) programs with key vendors.</li><li>Identify and deliver freight cost reduction and inventory optimisation initiatives.</li><li>Oversee purchase order accuracy and compliance with the Approved Vendor List (AVL).</li><li>Maintain and enhance procurement policies in line with ISO/QMS standards.</li><li>Collaborate with production, engineering, and warehousing to ensure material availability.</li><li>Introduce lean practices to improve procurement workflows.</li><li>Support forecasting and long-term supplier planning for greater business visibility.</li></ul> Requirements: <ul><li>Degree/diploma in Business, Supply Chain, Engineering, or related field.</li><li>5+ years’ purchasing/procurement leadership in manufacturing or engineering.</li><li>Proven record in supplier management, cost reduction, and KPI delivery.</li><li>Strong commercial and financial acumen with experience in international supplier agreements.</li><li>Advanced MS Office skills, especially Excel.</li></ul> Key Competencies<ul><li>Inspirational leadership and team development skills.</li><li>Excellent negotiation and supplier management ability.</li><li>Analytical, detail-oriented, and solutions-focused.</li><li>Resilient, adaptable, and results-driven.</li><li>Strong cross-functional communication skills.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Purchasing and Procurement Manager

Manufacturing Engineer Location: Shannon, Co. Clare About the Company Our client is a leading manufacturer with global expertise and a strong local presence in the precision engineering sector. They are known for innovation, quality, and delivering exceptional solutions to customers worldwide. As operations continue to grow, they are seeking a skilled and motivated Manufacturing Engineer to join their expanding team in Shannon. The Role This is a key position for a dynamic engineer with experience in fast-paced, multinational manufacturing environments. You will be responsible for developing, optimising, and supporting manufacturing processes from prototype stage through to full-scale production, ensuring efficiency, quality, and continuous improvement across the operation. Key Responsibilities <ul><li>Provide manufacturing engineering support to production teams, customers, and suppliers.</li><li>Plan, design, and implement new manufacturing processes that are efficient, scalable, and easy to integrate.</li><li>Manufacture and validate prototypes, scaling successful designs into full production.</li><li>Identify and deliver process, equipment, and method improvements to enhance quality, reduce costs, and improve delivery performance.</li><li>Apply and maintain lean manufacturing principles, driving continuous improvement initiatives.</li><li>Contribute to the development and rollout of a new ERP system.</li><li>Maintain clear and accurate technical documentation in line with engineering standards.</li><li>Collaborate with cross-functional teams to support flexibility and innovation.</li><li>Suggest new products or services to enhance offerings to customers.</li></ul> Skills & Experience Required <ul><li>Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related field.</li><li>2–5 years’ experience in a manufacturing or industrial engineering role.</li><li>Proven track record in process development, optimisation, and improvement projects.</li><li>Experience in prototype manufacturing, testing, and validation.</li><li>Strong knowledge of lean manufacturing principles (Lean Six Sigma Green Belt or higher desirable).</li><li>Hands-on experience with equipment setup, troubleshooting, and production support.</li><li>ERP system experience; implementation experience is an advantage.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Our client, a market leader in smart home life safety devices and IoT innovation, is seeking a highly skilled R&D Product Validation Specialist to join their dynamic development team. This role plays a vital part in the product development lifecycle by ensuring products meet the highest quality, safety, and compliance standards before reaching market. The successful candidate will work at the forefront of electronic and IoT validation—testing both hardware and software in a hands-on R&D environment. If you are methodical, technically adept, and passionate about quality assurance, this is an exciting opportunity to contribute to cutting-edge, life-saving technology. Key Responsibilities<ul><li>Full Lifecycle Product Validation: Validate new smart home devices, including alarm systems, IoT sensors, RF modules, and connected gateways. Extend validation to mobile applications, user interfaces, and cloud portals.</li><li>Hardware Prototyping & Electrical Testing: Assemble and build prototypes. Perform a range of electrical safety and compliance tests, including ESD, surge, and transient testing.</li><li>Issue Diagnosis & Resolution: Work closely with R&D and design engineers to identify and troubleshoot issues in circuit design, firmware, and system integration.</li><li>Test Planning & Reporting: Develop and execute structured validation plans. Accurately document test processes and outcomes, contributing to technical reports and quality records.</li><li>Quality Assurance Support: Ensure all products meet internal standards and external regulatory requirements. Support continuous improvement and documentation of validation processes.</li></ul> Candidate Profile Essential Experience & Skills: <ul><li>Minimum 2 years’ hands-on experience testing electronic hardware and embedded software—ideally in IoT, home security, or consumer electronics.</li><li>Strong understanding of electronics principles and proficiency in reading and interpreting circuit schematics.</li><li>Skilled in using test equipment such as oscilloscopes, multimeters, and signal generators.</li><li>Confident in soldering and rework, including surface mount technology (SMT).</li><li>Excellent problem-solving skills, high attention to detail, and structured analytical thinking.</li><li>Ability to work independently and collaboratively, managing tasks in alignment with project timelines.</li><li>Degree or qualification in Electronic/Electrical Engineering or equivalent practical experience.</li></ul> Desirable Experience: <ul><li>Experience with automated testing tools (e.g., Selenium, LabView).</li><li>Familiarity with defect tracking systems (e.g., Jira).</li><li>Comfortable working with mains-powered devices.</li><li>Holding a relevant QA certification (e.g., ISTQB) would be a plus.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

R&D Product Validation Specialist

Head of Information Security Role Overview We’re seeking an experienced Head of Information Security to lead and mature our client’s global security and compliance strategy. You’ll own the implementation and oversight of frameworks like ISO 27001, SOC, and HIPAA, ensuring the protection of sensitive health and operational data. Ideal candidates will have hands-on experience in regulated environments (preferably healthcare), a deep understanding of cloud security, and a strong track record of driving security certifications in fast-paced or startup settings. Key Responsibilities <ul><li>Develop and lead the organization's information security program.</li><li>Define and enforce policies aligned with ISO 27001, NIST CSF, and HIPAA.</li><li>Oversee risk assessments, incident response, and third-party risk.</li><li>Lead audits and certification efforts (e.g., ISO 27001, FedRAMP, HIPAA).</li><li>Partner with DevOps on secure cloud architecture and with engineering on DevSecOps.</li><li>Drive company-wide security awareness and training.</li><li>Represent security in customer, board, and regulatory discussions.</li><li>Act as or support the Data Protection Officer for GDPR compliance.</li></ul>Required Qualifications <ul><li>7+ years in information security, including 2+ years in a leadership role.</li><li>Proven success with ISO 27001 certification and HIPAA compliance.</li><li>Strong grasp of cloud-native security (AWS, Azure, or GCP).</li><li>Experience in regulated sectors such as healthcare or MedTech.</li><li>Effective communicator with both technical and non-technical audiences.</li></ul>Preferred Qualifications <ul><li>Certifications: CISSP, CISM, CISA, CCSP, or ISO 27001 Lead Implementer.</li><li>Familiarity with NIST SP 800-53, FISMA, and FedRAMP.</li><li>Knowledge of IoT security, Bluetooth, or firmware threat modeling.</li><li>Experience with DevSecOps and CI/CD pipeline security.</li></ul>What We Offer <ul><li>A senior leadership role in an impactful MedTech startup.</li><li>Competitive salary and equity.</li><li>Flexible/hybrid work environment.</li><li>The opportunity to shape a security program from the ground up.</li><li>A collaborative, mission-driven team culture.</li></ul>

Head of Information Security

About the Role We’re recruiting on behalf of a fast-growing healthcare technology company seeking a Head of Information Security to lead and evolve their global security and compliance posture. This is a pivotal leadership role with broad responsibility across security strategy, risk, cloud infrastructure, compliance (HIPAA, ISO 27001, FedRAMP readiness), and data protection. You’ll collaborate cross-functionally to ensure a proactive and scalable approach to protecting sensitive health and operational data. The ideal candidate will be a hands-on security leader with proven experience in regulated environments—preferably healthcare or digital health—and a track record of successfully delivering security certifications in startup or growth-stage companies. Key Responsibilities<ul><li>Design, implement, and continuously mature the company’s information security program.</li><li>Define and enforce policies aligned with ISO 27001, HIPAA, NIST CSF, and other relevant standards.</li><li>Lead risk assessments, vulnerability management, incident response, and third-party risk processes.</li><li>Prepare for and manage external audits (e.g., ISO 27001, HIPAA, FedRAMP readiness).</li><li>Partner with DevOps to implement secure cloud architectures (AWS/Azure/GCP).</li><li>Promote secure development practices in engineering, QA, and clinical workflows (DevSecOps).</li><li>Drive security awareness and training programs across the organization.</li><li>Act as a key voice in customer engagements, board-level discussions, and compliance matters.</li><li>Serve as (or support) the Data Protection Officer (DPO) for GDPR-related activities.</li></ul> Required Experience & Qualifications<ul><li>7+ years in information security, with 2+ years in a leadership or head-of-role capacity.</li><li>Proven experience achieving and maintaining ISO 27001 certification.</li><li>Deep understanding of HIPAA and relevant healthcare compliance frameworks.</li><li>Working knowledge of NIST CSF and FedRAMP (readiness or implementation stage).</li><li>Strong cloud security expertise in AWS, Azure, or GCP environments.</li><li>Demonstrated success managing security audits, risk assessments, and remediation efforts.</li><li>Experience in regulated industries—especially healthcare SaaS or medical devices.</li><li>Excellent communication and stakeholder management skills (technical and non-technical audiences).</li></ul> Preferred Qualifications<ul><li>Professional certifications (CISSP, CISM, CISA, CCSP, ISO 27001 Lead Implementer).</li><li>Familiarity with U.S. federal compliance standards (NIST SP 800-53, FISMA).</li><li>Exposure to IoT or device-level security (e.g., Bluetooth, firmware threat modeling).</li><li>Hands-on experience with DevSecOps pipelines and CI/CD security tools.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Electronic Engineer (NPI) We're working with a medical device company in Galway that is actively recruiting for a Senior Electronic Engineer to support New Product Introduction (NPI) and scale manufacturing. This role will span process development and support for product industrialization, including smooth integration into manufacturing environments. Key Responsibilities <ul><li>Drive NPI efforts, including design transfer and collaboration with contract manufacturers and internal stakeholders.</li><li>Partner with suppliers and vendors to ensure compliance with technical specs and quality standards.</li><li>Support process development, DFM/DFT strategies, and test systems for manufacturing scalability.</li><li>Participate in design reviews, FMEAs, and verification/validation activities.</li><li>Maintain documentation to support regulatory compliance and production readiness (e.g., design history files).</li><li>Troubleshoot complex issues during both development and production phases.</li><li>Mentor junior engineers and provide cross-functional technical leadership.</li></ul> Requirements; <ul><li>Bachelor’s or Master’s in Electronic Engineering, Computer Engineering, or similar.</li><li>7+ years of experience in electronic hardware design and production ramp-up.</li><li>Proven success in NPI and working with regulated manufacturing processes.</li><li>Strong grasp of embedded systems, sensor integration, and analog/digital circuit design.</li><li>Proficiency with design tools like Altium Designer and hands-on experience with lab test equipment.</li><li>Excellent analytical, debugging, and cross-functional collaboration skills.</li></ul> Desirable: <ul><li>Experience integrating camera modules or working with imaging systems.</li><li>Familiarity with ISO 13485 or other regulated quality systems.</li><li>Knowledge of DFM/DFT principles and scalable design practices.</li><li>Scripting or firmware experience (e.g., Python or embedded C) a bonus.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Electronic Engineer (NPI)

Documentation Specialist - Contract The Documentation Specialist is responsible for the coordination, execution, and maintenance of manufacturing documentation in a cGMP-regulated environment. This role ensures the timely progression of documents through all lifecycle stages and supports production, inventory, and quality compliance activities through accurate and efficient document control processes. Key Responsibilities: <ul><li>Coordinate internal and external review and approval of manufacturing documents.</li><li>Ensure documentation progresses in line with site policies, cGMP, and GDP requirements.</li><li>Act as the main point of contact for documentation processes within manufacturing.</li><li>Manage the flow of documents in and out of ABB documentation systems.</li><li>Support new product introduction (NPI), technology transfers (TT), and routine manufacturing through documentation readiness.</li><li>Revise, update, and format manufacturing documentation including MBRs, SOPs, forms, logbooks, and label templates.</li><li>Ensure alignment between batch records and executed processes.</li><li>Investigate documentation-related issues with quality/compliance impact and document outcomes.</li><li>Track operations/business metrics and report on schedule adherence and manufacturing KPIs.</li><li>Provide training and guidance on new or updated documentation.</li><li>Support inventory management and production documentation in SAP.</li><li>Interface with planning and procurement to support batch and purchase order management.</li><li>Maintain accurate records and ensure efficient execution of documentation across all manufacturing stages.</li></ul> Qualifications & Requirements: <ul><li>Bachelor’s Degree (Science or related field preferred) or equivalent experience.</li><li>Minimum 1 year of experience in document control/records management in a regulated industry.</li><li>Experience in a GMP manufacturing environment strongly preferred.</li><li>Proficient in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint, Visio).</li><li>Expert in formatting, proofing, and editing GMP documentation for compliance.</li><li>Familiarity with electronic document management systems.</li><li>Demonstrated ability to manage documentation timelines in a fast-paced, deadline-driven environment.</li><li>Knowledge of SAP for inventory and production documentation is highly advantageous.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Visual Inspection Engineer   Responsibilities: <ul><li>To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.</li><li>Develop and modify procedures as needed to support the manufacturing operation.</li><li>Participate in process, equipment, and facilities validations efforts and projects implementations.</li><li>Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.</li><li>Execute protocols in a timely basis to meet the project schedule requirements.</li><li>Participate and lead (as required) Process FMEAs for Visual Inspection</li><li>Establish, Lead and Optimize the process for certification of technicians for visual inspection.</li><li>Establish and maintain the defect library.</li><li>Establish and execute the process for the trending of Visual Inspection Defects.</li><li>Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements</li><li>Provide Technical Input to guide the development of SOPs for Visual Inspection.</li><li>Leadership of manufacturing and validation activities during project life cycle.</li><li>Coordination with internal/external stakeholders for the evaluation of particles/defects</li><li>Support of technical transfers for future product introductions to the site.</li><li>Investigate process exceptions or malfunction incidents affecting the process.</li><li>To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required</li><li>Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.</li></ul> Essential Requirements: <ul><li>A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)</li><li>At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.</li><li>At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.</li><li>Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.</li><li>Experience in clean utilities is desirable</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Visual Inspection Engineer

Project Engineer - Automation Job Summary The Project Engineer is responsible for safely coordinating and leading projects associated with Automation, Aseptic processing, new processing equipment, packaging, new Facility builds or modifications/extensions. The primary responsibility of the role is to ensure that the project meets its agreed goals/targets on time and on budget. The engineer reports project progress to the Project Manager to ensure the equipment/facility design and goals/targets are achieved. Responsibilities <ul><li>Safely coordinate the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g. autoclaves, LAF units, moulds, extruders, packaging equipment, automated vision inspection systems, lyophilsers, isolators, containment booths, stopper processing eipment and equipment upgrades – both hardware and SCADA.</li><li>Coordination of equipment installation and services hook up, working with equipment vendors and engineering personnel.</li><li>Lead the Project Team or support the Project Manager in Factory Acceptance Testing program.</li><li>Coordination of all equipment documentation requirements.</li><li>Commissioning of equipment for validation activities.</li><li>Preparation of equipment training and maintenance protocols.</li><li>Report into the Project Manager on project progress and advice/support on key project outcomes</li><li>Contribute in a team environment on specific technical problem solving forums associated with product manufacture, aseptic fill and Packaging.</li><li>Deliver Process improvement projects.</li><li>Work with the relevant Business Unit team leaders to implement improvement opportunities</li><li>Lead regular Equipment/Facility Project review meetings.</li><li>Attend the weekly Tier Meetings.</li><li>Attend monthly Department Meetings</li></ul> Requirements <ul><li>Third level qualification in an Engineering or Science or equivalent discipline/experience (Automation)</li><li>Experience of working within either the medical device or bio/pharmaceutical industry would be an advantage but not necessary. 5 years+ experience.</li><li>Project Management experience is preferable but not necessary</li><li>Interpersonal skills required to operate in a multi-function project team set up.</li><li>Ability to work within a team and on own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project.</li></ul> Essential Knowledge, Skills & Abilities: <ul><li>Experience of working on a team, including strong organizational and time management skills.</li><li>Exposure to process/equipment projects preferred.</li><li>Experience in a GxP regulated environment is preferred.</li><li>Experience with manufacturing systems is preferred.</li><li>Proficient in Windows Operating System, Microsoft Office and a good understand of PLC and Scada systems preferred.</li><li>Flexibility to respond to production issues outside normal business hours.</li><li>Ability to learn new and different technologies</li><li>Undertake any training or travel that the role may require.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Director of Operations – Limerick The Operations Director will play a key role in scaling and optimizing production operations at a high-precision medical device manufacturing facility. Collaborating with senior leadership, this role ensures manufacturing capacity meets growing demand while maintaining top-tier quality and regulatory compliance. Key Responsibilities <ul><li>Manufacturing Oversight: Lead all production lines to meet targets in output, quality, and delivery while scaling operations efficiently.</li><li>Operational Excellence: Drive continuous improvement using Lean, Six Sigma, or equivalent methodologies.</li><li>Quality & Compliance: Partner with QA to align operations with ISO 13485 and regulatory standards.</li><li>Supply Chain: Manage raw materials sourcing, vendor relationships, and inventory control.</li><li>Strategic Planning: Execute capacity planning, capital investment strategies, and tech integration.</li><li>Team Leadership: Build and mentor high-performing, safety-focused production teams.</li></ul>Required Experience & Skills <ul><li>10+ years in manufacturing leadership within precision or regulated industries</li><li>Strong background in toolmaking, machining, or related trades</li><li>Demonstrated success with Lean, Six Sigma, or TPM implementation</li><li>Data-driven problem solver with rapid troubleshooting abilities</li><li>Familiarity with ISO 13485 and FDA standards</li></ul>Preferred Qualifications <ul><li>Degree in Engineering, Operations, Manufacturing, or related field</li><li>Lean Six Sigma certification (Green or Black Belt)</li><li>Experience with digital manufacturing, CAD/CAM, or Industry 4.0 tools</li></ul>Leadership & Culture Fit <ul><li>Hands-on leadership—comfortable engaging directly with floor teams</li><li>Results-driven and pragmatic</li><li>Strong cross-functional collaborator</li><li>Composed under pressure in dynamic, growth environments</li><li>Future-focused with a proactive mindset</li></ul>

Director of Operations

Program Manager Location: Mayo Role Overview: The eBR Program Manager will lead the implementation of electronic Batch Records (eBR) and Review by Exception (RBE) at the Mayo site. This role is responsible for managing the project end-to-end—covering requirements gathering, system design, validation, and change management—ensuring alignment with Quality and Digital Transformation strategies. Key Responsibilities:<ul><li>Develop and manage a detailed project plan covering timelines, resources, and milestones.</li><li>Lead cross-functional teams and external partners through all phases of implementation.</li><li>Ensure compliance with IT and Quality policies, including system validation.</li><li>Track and report project costs, savings, and overall ROI.</li><li>Provide regular updates to senior leadership and contribute to broader Digital Transformation initiatives.</li><li>Support process redesign and stakeholder engagement to drive adoption.</li><li>Promote EHS and compliance across all project activities.</li></ul>Qualifications & Skills:<ul><li>Bachelor’s degree in Engineering, Science, or Technology (preferred).</li><li>Project Management certification is a plus.</li><li>6+ years’ experience in manufacturing, supply chain, engineering, or related areas.</li><li>Strong project leadership and cross-functional collaboration skills.</li><li>Proven ability to influence stakeholders and manage complex programs.</li></ul>

Program Manager eBR

Senior Manufacturing Engineer – Limerick Temporary – 6 Month Contract - Strong Possibility of Extension Position: My client is seeking an experienced Senior Manufacturing Engineer to join their team in Limerick on an initial 6-month contract, with a strong likelihood of extension. This role will play a key part in supporting the completion of a full validation pack for a new automated packaging line, offering the opportunity to contribute significantly to a high-impact technical project. Responsibilities: <ul><li>Provide advanced technical and engineering support within the manufacturing cell.</li><li>Work closely with engineering leadership to deliver key business objectives.</li><li>Drive the development and implementation of world-class manufacturing practices in a production environment.</li><li>Lead technical support for specific product and process-related issues.</li><li>Monitor line performance and implement structured improvement activities to optimize overall equipment effectiveness (OEE).</li><li>Lead or support validation activities including URS, VP, DQ, EQ, MSA, and PQ.</li><li>Note: You will not be required to approve validations, but strong experience in drafting, executing, and leading these activities is essential.</li><li>Contribute significantly to validation documentation and execution for a new automated packaging line. Experience in packaging and/or automation is advantageous but not essential.</li><li>Conduct Gauge R&R studies and support validation for new products and processes.</li><li>Apply Six Sigma and Lean methodologies to structured problem-solving efforts.</li><li>Lead strategic projects (value stream and cross-functional), including scoping, approval, budgeting, execution, qualification, and handover.</li><li>Continuously monitor and report on key business metrics and proactively resolve performance issues.</li></ul> Requirements: <ul><li>Level 8 Degree in an Engineering discipline.</li><li>Minimum 2 years of experience in a manufacturing environment, with practical validation experience.</li></ul> Desired: <ul><li>Strong background in leading or supporting validation projects from URS through PQ.</li><li>Confident and effective decision-maker with the ability to influence stakeholders.</li><li>Excellent written and verbal communication skills.</li><li>Experience working in cross-functional teams and delivering technical projects.</li><li>Proven project management and process improvement capability.</li><li>Strong analytical and problem-solving skills with measurable results.</li><li>Ability to manage and prioritise multiple tasks in a fast-paced environment.</li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353861908885

Job Title: Service Engineer Location: Remote Status: Full-Time, Permanent Reports To: Technical Service Manager ________________________________________ Position Summary The Service Engineer is a vital member of the Service Team, responsible for providing high-quality technical support, service, and training to customers and distributors across Europe. This role requires a proactive, customer-focused professional with strong technical expertise and a willingness to travel regularly. ________________________________________ Key Responsibilities • Deliver on-site technical support across Europe to diagnose and resolve equipment issues. • Fulfil maintenance service contracts at customer locations in the Netherlands and Germany, using the Field Service App to perform required inspections and checks. • Travel a minimum of two days per week (excluding vacation weeks); some weeks may involve extended travel for customer visits or exhibitions. • Perform equipment installation and commissioning at customer sites. • Promote and sell maintenance service contracts during customer visits. • Troubleshoot and resolve issues via phone and email, ensuring all cases are logged accurately in Salesforce. • Conduct product demonstrations, highlighting equipment operation, features, and benefits—collaborating with the Sales Team as needed. • Provide technical training to distributors at the Galway facility; attend Galway-based training at least once per quarter for ongoing development. • Support setup and demonstrations at trade shows and exhibitions across Europe. ________________________________________ Qualifications and Requirements • Strong mechanical and electrical aptitude • Fluent in English (spoken and written) • Engineering or Electrical certificate/diploma preferred, or willingness to pursue relevant qualifications • Excellent communication and interpersonal skills • High attention to detail, accuracy, and conscientiousness • Strong organizational and time-management abilities • Proficient in Microsoft Excel, Word, PowerPoint, and other relevant business software (e.g., Salesforce, PDM, JDE, AX) • Flexible and adaptable to meet dynamic customer and business needs, including frequent travel ________________________________________ Core Competencies • Mechanical and electrical/electronic engineering skills • Ability to read and interpret technical drawings • Strong documentation and reporting capabilities • Self-starter with excellent prioritization and decision-making skills • Clear and professional communication with internal teams, distributors, and customers • Readiness and flexibility to travel frequently across Europe, sometimes on short notice For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Service Engineer

Mechanical Utilities Engineer Job Dept: Site Engineering Services Reports to: Engineering Manager Responsibilities:  <ul><li>Manage the execution of engineering and facilities-related projects within the group.</li><li>Lead and implement equipment and process improvement initiatives across manufacturing and utilities.</li><li>Ensure the effective execution of day-to-day preventive and demand maintenance activities.</li><li>Establish performance goals, schedules, and timetables in collaboration with the Site Engineering Services Manager.</li><li>Support and assist in managing project plans across manufacturing, utility, and facility areas.</li><li>Coordinate maintenance activities to align with required schedules and compliance standards.</li><li>Prepare capital expenditure (CapEx) requests related to facility, plant, and equipment needs.</li><li>Develop and maintain monthly engineering performance metrics, including ownership of the Site Maintenance Excellence Program to drive operational efficiencies and cost savings.</li><li>Ensure audit readiness and compliance with regulatory, corporate, and divisional engineering standards.</li><li>Deliver timely management reports and maintain performance against relevant budgets.</li><li>Promote cross-training within the department to sustain preventive maintenance objectives.</li><li>Uphold and enforce safety standards and safe work practices.</li><li>Implement continuous improvement through equipment and process upgrades.</li><li>Support manufacturing equipment maintenance to meet legal and corporate standards.</li><li>Liaise with Global Engineering and relevant stakeholders as needed.</li><li>Oversee internal and external project execution for plant-related initiatives.</li><li>Ensure full implementation of all relevant Quality, Engineering, and Safety policies.</li><li>Supervise external contractors, including the development of performance metrics for third-party service providers.</li><li>Drive quality and performance in vendor relationships through negotiation and management.</li><li>Prepare and implement timely Corrective and Preventive Action (CAPA) plans.</li></ul> Requirements: Essential Requirements: <ul><li>Bachelor’s Degree: Engineering (Mechanical, Chemical, Electrical, Biomedical, Electronics) or Relevant Discipline</li></ul> Desired Requirements: <ul><li>Experience in Chilled Water, boilers, Potable Water distribution, Compressed Air Generation, LPHW, Building Management Systems, Environmental Management Systems, Electricity, Building Safety Systems and Building regulations is desirable.</li></ul>Technical/Business Knowledge -Job Skills/Experience Required: <ul><li>5+Years experience in Facility and Utility Engineering, preferably in a cGMP environment.</li><li>It may be necessary to re-design elements of manufacturing / utility / facility machinery to adapt to process conditions in order to improve efficiency with a demonstrated track record in managing budgets.</li><li>Experience in a Electricity, LPHW, Chilled Water and Potable Waer distribution, Compressed Air Generation, Building Management Systems, Environmental Management Systems, Building Safety Systems and Building regulations is desirable.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Mechanical Utilities Engineer

Senior Quality Engineer Location: Galway, Ireland About the Role We are looking for an experienced Senior Quality Engineer to join our team in Galway. This role is key to ensuring product and process quality for medical devices in compliance with global regulatory standards. Key Responsibilities <ul><li>Support new product introductions (NPI) and existing manufacturing operations.</li><li>Lead non-conformance, CAPA, and complaint investigations.</li><li>Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and MDR.</li><li>Collaborate with cross-functional teams on design controls, risk management, and validation.</li><li>Support internal and external audits and drive continuous improvement.</li><li>Manage supplier quality and mentor junior team members.</li></ul>Qualifications <ul><li>Degree in Engineering, Science, or related field.</li><li>5+ years’ experience in quality within a medical device or regulated industry.</li><li>Strong knowledge of regulatory standards, CAPA, and validation.</li><li>Experience with Lean/Six Sigma tools; CQE or Green Belt a plus.</li><li>Excellent problem-solving and communication skills.</li></ul>

Senior Quality Engineer

Position: Mechanical Program / Project Lead Location: Mayo Fixed Term Contract The Role: Our client, a global leader in the food and beverage industry, is seeking a highly skilled and dynamic Software and Mechanical Program/Project Lead to join their team on a fixed term contract. They are seeking an individual who will drive innovative solutions and manage complex projects that blend software and mechanical engineering within manufacturing operations. The candidate will be responsible for ensuring the seamless integration of mechanical systems and software applications, optimizing production processes, and maintaining high standards of quality and efficiency. They will be responsible for overseeing and coordinating the development and implementation of software and mechanical projects and will lead cross-functional teams to ensure projects are completed to a high standard, on time, and within budget. Responsibilities: <ul><li>Oversee the entire lifecycle of software and mechanical projects, from planning and design to testing and implementation.</li><li>Lead the design and development of mechanical systems and software applications, considering budget, timelines, and resource constraints.</li><li>Lead and mentor cross-functional teams, including engineers, designers, and technicians, to achieve project goals.</li><li>Ensure all projects meet high standards of quality and comply with national and local regulations and standards.</li><li>Troubleshoot issues and develop innovative solutions to resolve them promptly.</li><li>Conduct regular tests and experiments to improve components and processes, staying up to date with industry trends and technological advancements.</li><li>Utilize CAD and 3D CAD software to plan and execute mechanical design projects and integrate software applications for enhanced functionality.</li></ul> Qualifications/Requirements: <ul><li>Degree in Mechanical Engineering, Software Engineering, or a related field.</li><li>Prior experience working as a mechanical design engineer or software developer, or in a similar role within the manufacturing sector.</li><li>Proven ability to manage projects from start to finish, ensuring high standards and timely completion.</li><li>Strong analytical and problem-solving abilities, able to devise innovative solutions to complex problems.</li><li>Proficiency with tools such as CAD and 3D CAD software.</li><li>Strong verbal and written communication skills.</li></ul>

Project Manager / Controls

Senior Manufacturing Engineer Location: Galway Department: Operations Type: Full-Time Position Overview The Senior Manufacturing Engineer is responsible for supporting and optimizing the manufacture of medical device products. This includes leading process improvements, managing equipment and materials, providing production line support, and ensuring operational efficiency in compliance with quality and regulatory standards. Key Responsibilities Manufacturing & Process Engineering <ul><li>Lead manufacturing projects to develop, optimize, and validate production processes.</li><li>Collaborate with R&D and Quality teams to design and improve manufacturing procedures and workflows.</li><li>Execute process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in line with the Quality Management System (QMS).</li></ul>Operations Support <ul><li>Provide routine support to production operations, helping the team meet daily, weekly, and monthly manufacturing targets.</li><li>Troubleshoot and resolve product, process, and equipment issues in collaboration with QA and operations teams.</li></ul>Equipment Management <ul><li>Select, install, maintain, and monitor manufacturing equipment to ensure optimal performance.</li><li>Address equipment problems and adjust process parameters as needed.</li></ul>Continuous Improvement <ul><li>Apply principles of Lean, Six Sigma, Statistical Process Control (SPC), and Key Performance Indicator (KPI) analysis to drive continuous improvement.</li><li>Identify and implement cost-effective solutions to reduce cost of goods sold (COGs) as part of commercial readiness and scale-up plans.</li></ul>Required Skills & Experience <ul><li>Bachelor’s degree (Level 8) in Engineering or a related field.</li><li>Minimum of 5 years' experience in the medical device industry.</li><li>Proven expertise in manufacturing process development and equipment management.</li><li>Solid understanding of quality management systems (QMS), process controls, and regulatory compliance.</li><li>Strong problem-solving and analytical skills.</li><li>Excellent communication skills with the ability to liaise effectively with internal and external stakeholders.</li><li>Self-motivated, with a demonstrated ability to work both independently and within cross-functional teams.</li><li>Strong organizational, presentation, and project management abilities.</li></ul>Preferred Attributes <ul><li>Experience working in a start-up or scale-up medical device environment.</li><li>Familiarity with urology or similar therapeutic areas is a plus.</li></ul>

Senior Manufacturing Engineer

MES Engineer (Mid-level) - Westport   Purpose Maintain the MES (POMSnet) environment; to author & maintain recipes & worksheets for our clients site. Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring.   Responsibilities <ul><li>Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic</li><li>Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.</li><li>Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.</li><li>Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.</li><li>Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-arounds and fixes identified.</li><li>Liaise with Global MES on Westport required system improvements.</li><li>Provide support to other MES system users as required to ensure business continuity.</li><li>Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.</li><li>Keep other recipe authors up to date on MES changes</li><li>Documentation of all activities in line with cGMP requirements.</li><li>Cross training within the team and training of new team members.</li><li>Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.</li><li>Adheres to and supports all EHS standards, procedures and policies.</li></ul>  Requirements <ul><li>Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.</li><li>A minimum of 2 years authoring experience preferably using POMSnet.</li><li>Be familiar with MES application and configuration rules and requirements including interfacing (preferably POMSnet).</li><li>Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.</li><li>A good knowledge of IT systems is required for this role.</li><li>SAP knowledge/experience in MM, PP and IM modules an advantage.</li><li>Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times.</li></ul>  For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

MES Engineer

Quality Assurance Specialist/Qualified Person Dept: Quality Assurance Reports to: Quality Operations Lead   Responsibilities: <ul><li>Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.</li><li>Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured at our clients Biologics site .</li><li>To ensure that products manufactured at our clients biologics site are manufactured in accordance with the relevant GMPs.</li><li>The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.</li><li>To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.</li></ul>  Requirements: <ul><li>Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.</li><li>MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC</li><li>5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.</li><li>2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.</li></ul>  For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

QA Complaince Specialist / Qualified Person

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<h5>INVESTED IN YOUR SUCCESS.</h5><h5>What we do is more than a job.</h5>At Sterling, we work every day to create solutions to our clients&rsquo; business challenges while advancing our employees&rsquo; career objectives. We support your team in everything we do, from cutting-edge process development to hiring for your next success. Sterling drives expected outcomes while ensuring safety and compliance within your most complex projects.

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<h5>WHAT WE BUILD ON</h5><h5>At Sterling, we are driven by our values.</h5>For more than five decades, our commitment to quality has been the cornerstone of our success. We always act with integrity&mdash;taking responsibility for our work, caring for our people, and staying focused on safety and sustainability. Respect for people is at the heart of our business&mdash;clients and employees alike. We have an unrelenting focus on inclusion - we are a diverse, well-rounded team of thinkers and doers that embrace all perspectives. This culminates in a positive impact on the work we do.

WHAT WE BUILD ON<h2>At Sterling, we are driven by our values.</h2>For more than five decades, our commitment to quality has been the cornerstone of our success. We always act with integrity&mdash;taking responsibility for our work, caring for our people, and staying focused on safety and sustainability. Respect for people is at the heart of our business&mdash;clients and employees alike. We have an unrelenting focus on inclusion - we are a diverse, well-rounded team of thinkers and doers that embrace all perspectives. A diverse, well-rounded team of thinkers and doers helps Sterling embrace all perspectives. This culminates in a positive impact on the work we do.

<h5 style="text-align: center;">Since 1969, Sterling has been focused on cultivating relationships and&nbsp;is in the business of building trust.</h5>

INVESTED IN YOUR SUCCESS<h2>What we do is more than a job.</h2>At Sterling, we work every day to create solutions to our clients&rsquo; business challenges while advancing our employees&rsquo; career objectives. We support your team in everything we do, from cutting-edge process development to hiring for your next success. Sterling drives expected outcomes while ensuring safety and compliance within your most complex projects.

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<h2>PROUD TO BE WOMAN-OWNED.</h2><div class="flex-shrink-0 flex flex-col relative items-end"><div><div class="pt-0"><div class="gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full"><div class="relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8">&nbsp;</div></div></div></div></div><div class="group/conversation-turn relative flex w-full min-w-0 flex-col agent-turn"><div class="flex-col gap-1 md:gap-3"><div class="flex max-w-full flex-col flex-grow"><div class="min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words [.text-message+&amp;]:mt-5" dir="auto" data-message-author-role="assistant" data-message-id="497c14f8-4331-4cd4-a0a0-847f5c2bf610" data-message-model-slug="gpt-4o"><div class="flex w-full flex-col gap-1 empty:hidden first:pt-[3px]"><div class="markdown prose w-full break-words dark:prose-invert light">We're excited to announce that Sterling Engineering Limited has officially met the qualifications to be named a Certified Women&rsquo;s Business Enterprise by WeConnect International!This certification reflects our commitment to diversity, leadership, and excellence, reinforcing our dedication to empowering women in business.&nbsp;We&rsquo;re proud to continue building strong partnerships and delivering top-quality engineering and staffing solutions with this recognition.<img src="https://cdn.sourceflow.co.uk/yi17tb2pmbvmyho8k83htie7aurb" alt="" width="400" height="179">&nbsp;</div></div></div></div></div></div>

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<h2>Engineering Services</h2><h5>Take your projects from planning to reality.</h5>Every project has a range of challenges that need to be met. If your organisation seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyse problems and design solutions.

<h2>Professional Services</h2>Take your projects from planning to reality.Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Professional Services</h2><h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Engineering Services</h2><h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

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<h3 style="text-align: center;">Outsourcing engineering project&nbsp;services enable companies to save time,&nbsp;money, and resources.</h3>

<h2 style="text-align: center;">PROJECT LIFE CYCLE</h2>End-to-end project delivery or a la carte services support all engineering and manufacturing stages.

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Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Professional Services</h2>&nbsp;<h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

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<h4>THE STERLING ADVANTAGE.</h4><ul><li>Dedicated Delivery Teams:<ul><li>Project Manager</li><li>Coordinator</li><li>Researchers</li><li>Recruiters</li><li>Onsite Coordinator (as needed)</li></ul></li><li style="font-weight: bold;">Coordinate and manage secondary suppliers</li><li style="font-weight: bold;">Highly competitive pricing with centralised invoicing</li><li style="font-weight: bold;">Quality compliance and access to top talent</li><li style="font-weight: bold;">Tracking and analytics</li><li style="font-weight: bold;">Monthly/quarterly status reports</li><li style="font-weight: bold;">Flexible benefit programs</li><li style="font-weight: bold;">Technical expertise to deliver a statement of work</li></ul>

At Sterling, we pride ourselves on our exceptional recruitment process. We build strong partnerships with our clients, providing high-touch communication and in-depth prescreening to ensure the perfect match. Our advanced technology and extensive candidate database allow us to effortlessly locate technical candidates that may be difficult to find through other recruiting means. In addition, our dedicated industry-focused talent teams are profoundly knowledgeable and assess technical skills, cultural fit, and alignment with our client&rsquo;s values. We also provide comprehensive onboarding support for a seamless transition and long-term success. As a result, we deliver top-notch talent that aligns perfectly with our client&rsquo;s goals and culture.

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<h3 style="text-align: center;">Professional Service Offering</h3>As a Managed Service Provider (MSP), we specialise in managing and overseeing the staffing process for our clients. Our primary focus is to partner with you to help you efficiently acquire and manage your contingent workforce.&nbsp;

<h4>THE STERLING ADVANTAGE.</h4><ul><li>Dedicated Delivery Teams:<ul><li>Project Manager Coordinator Researchers Recruiters Onsite Coordinator (as needed)</li></ul></li><li>Coordinate and manage secondary suppliers</li><li>Highly competitive pricing with centralized invoicing</li><li>Quality compliance and access to top talent</li><li>Tracking and analytics</li><li>Monthly/quarterly status reports</li><li>Flexible benefit programs</li><li>Technical expertise to deliver a statement of work</li></ul>&nbsp;&nbsp;

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<h5>ENGINEERING SERVICES</h5>Sterling&rsquo;s experienced engineers can guide you from concept to prototype production or testing to manufacturing. With experience in multiple industries, we can deliver a creative approach to the project, accelerating time to market.Our experienced, multi-disciplined team of Project Managers, Engineers and Designers, led by licensed Professional Engineers (PE), provide Project Management, Engineering, Design, Commissioning, Qualification, and Validation (CQV) to Manufacturing, OEM, and R&amp;D customers.&nbsp;<h5>PROFESSIONAL SERVICES</h5>Our recruiters are experts in their related industries and talent skill sets. We leverage our industry relationships built since 1969, propriety database, and invested resources to connect you with the best engineering and technical talent.<ul><li>Recruiting structure driven by industry disciplines</li><li>We fully prescreen &amp; qualify candidates before submittal</li><li>90%+ of our business is from repeat clients</li></ul>

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Our recruiters are experts in their related industries and talent skill sets. We leverage our industry relationships built since 1969, propriety database, and invested resources to connect you with the best engineering and technical talent.&nbsp;<ul><li style="font-weight: bold;">Recruiting structure driven by industry disciplines</li><li style="font-weight: bold;">We fully prescreen &amp; qualify candidates before submittal</li><li style="font-weight: bold;">90%+ of our business is from repeat clients</li><li style="font-weight: bold;">2022 Manage HR Top Contingent Workforce Services Company</li><li>Best of Staffing Awards <ul><li>Client Satisfaction &ndash; 11 Consecutive Years  Talent Satisfaction &ndash; 10 Consecutive Years  Employee Satisfaction &ndash; 4 Consecutive Years</li></ul></li></ul>

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<h2>Service Summary</h2>Elevate your product development journey with our cutting-edge Product Engineering services. We specialize in guiding your product through every stage of development. Our focus on scalability and future-proofing anticipates growth and technological advancements, providing a solid foundation for sustained success. Choose our Product Engineering services for a strategic partnership that goes beyond development &ndash; it&rsquo;s about shaping the future of your product portfolio with innovation, efficiency, and quality at its core.<table style="border-collapse: collapse; width: 100.17%; height: 35px;" border="1"><colgroup><col style="width: 49.8305%;"><col style="width: 49.8305%;"></colgroup><tbody><tr style="height: 17.5px;"><td style="height: 17.5px;">Concepting</td><td style="height: 17.5px;">Detailing</td></tr><tr style="height: 17.5px;"><td style="height: 17.5px;">Product development</td><td style="height: 17.5px;">Reverse engineering</td></tr><tr><td>Simulation</td><td>Materials selection</td></tr><tr><td>Design for manufacturability</td><td>Prototyping</td></tr><tr><td>&nbsp;</td><td>&nbsp;</td></tr></tbody></table>

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<h1>Product Engineering</h1>Let&rsquo;s engineer a solution together.&nbsp;

<h1>Life Sciences Staffing Solutions</h1>

<h3>Did you know Sterling also provides outsourced design and engineering solutions for the life science industry?</h3>Sterling Engineering has decades of experience working on complex, highly technical projects across various life science clients. We have streamlined our processes, best practices, and customization of manufacturing systems to meet your needs &ndash; saving you time and money.

<h1>Professional Services</h1>

Organisations may encounter various obstacles when searching for technical and engineering talent, such as:

<h3>Professional Services for Engineering providing</h3><h3>Temporary, Contract and Permanent Solutions.</h3>Don&rsquo;t see what you&rsquo;re looking for? Ask us about any skill or discipline.&nbsp;

At Sterling, we pride ourselves on our exceptional recruitment process. We build strong partnerships with our clients, providing high-touch communication and in-depth prescreening to ensure the perfect match. Our advanced technology and extensive candidate database allow us to effortlessly locate technical candidates that may be difficult to find through other recruiting means. In addition, our dedicated industry-focused talent teams are profoundly knowledgeable and assess technical skills, cultural fit, and alignment with our client&rsquo;s values. We also provide comprehensive onboarding support for a seamless transition and long-term success. As a result, we deliver top-notch talent that aligns perfectly with our client&rsquo;s goals and culture.

<h3>Industry Leading Staffing &amp; Recruiting</h3>

<h1>Project Management</h1>Let’s engineer a solution together.

<h1>Start-Up &amp; Documentation</h1>Let&rsquo;s engineer a solution together.&nbsp;

<h1>Strategy</h1>Let&rsquo;s engineer a solution together.&nbsp;

<h1>Transportation</h1>

<h2>JOIN OUR INTERNAL TEAM</h2>

<h1>Join Our Internal Team</h1>

<h2>Find Your Career With Sterling</h2>Sterling is fortunate to have a diverse and exceptional team of individuals with deep experience and expertise. We welcome professionals looking for new challenges, those starting their career journey, and those eager to seize new opportunities in their professional lives. With Sterling, you&rsquo;ll receive:<ul><li>Full benefits</li><li>Employment opportunities that give you flexibility and new challenges</li><li>Consistent opportunities that provide stability</li><li>Expert recruiters that advocate your unique skills</li></ul>

About Aidan
Aidan McNabola is a seasoned engineering professional with over 38 years of leadership experience in engineering and manufacturing, including 16 years specifically in sterile manufacturing across five sites. They have managed both direct and indirect teams of over 50 people and have extensive experience in corporate governance, including remediation, regulatory compliance, and inspections. Their background also includes leading greenfield operations from startup through acquisition and overseeing projects ranging from &euro;50,000 to &euro;150 million.
&nbsp;
Career Highlights:
<ul>
<li>
Viatris Pharmaceuticals &ndash; Senior Director of Engineering. (6 years) Managed engineering activities for the Sterile filling operations. Managed the conceptual and detailed design and install of a sterile cartridge filling and assembly line . Capex value 30mill. Euros.
</li>
<li>
Taro Pharma &ndash; Engineering Manager. Managed site engineering activities for a sterile fill finish facility. Conceptual and detailed design for two new Aseptic Fill Finish Lines.
</li>
<li>
Elan Pharma &ndash; Senior Project Manager. Front end study and detailed design for a new Fill Finish facility.
</li>
<li>
Allergan Pharmaceuticals &ndash; Engineering Manager. Design, Build, start up of a new Botox facility 20Mill.
</li>
<li>
GE Healthcare &ndash; Senior Project Manager/Operations. Managed sterile filling operations. Installation of a new sterile bottle filling line and start up operations.
</li>
</ul>
&nbsp;
Education &amp; Qualifications:&nbsp;
<ul>
<li>Degree Mechanical Engineering, University Limerick</li>
<li>Chartered Eng. FIEI.</li>
<li>PMP Certified</li>
<li>Green Belt Certified</li>
<li>Level 6 Coaching Cert.</li>
</ul>

Aidan McNabola

About Todd
With over 25 years of engineering and manufacturing leadership, Todd Johnson has consistently delivered operational excellence across complex, large-scale environments. He has provided direct and indirect oversight of teams exceeding 3,000 employees and has managed multi-plant operations with a focus on efficiency, compliance, and strategic growth. His expertise spans corporate governance, including remediation efforts, regulatory compliance, and successful navigation of inspections. Todd has led greenfield operations from initial startup through acquisition and has overseen capital projects ranging from $75,000 to $750 million, demonstrating a strong track record in project execution and organizational transformation.
Todd&rsquo;s leadership has been instrumental in several high-impact roles throughout his career. As VP of Engineering and Operations at Point BioPharma, he led the startup of manufacturing operations, including technology transfer, product development, and compliance with government regulatory requirements. His specialized expertise in radioligand therapies played a key role in the successful transition of business and operations to Eli Lilly. Todd also managed investor and client expectations, ensuring project delivery and securing necessary funding. At Zimmer Biomet, he served as Director of Engineering and Operations, overseeing highly customized medical device manufacturing. He implemented inventory controls, enhanced quality record management, and led a full overhaul of the quality systems. As Director of Engineering and Operations at Pharmedium, Todd focused on multi-site process standardization, led cleanroom expansions for continuous line operations, and optimized cycle times in batch manufacturing environments. At Baxter, he held the role of Senior Director of Engineering and Operations, where he drove continuous improvement initiatives to enhance OEE, managed large-scale CAPEX projects, led S&amp;OP processes, and oversaw new product introductions. He also played a pivotal role in the acquisition and integration of an aseptic filling/API facility in India. Early in his career at Abbott Laboratories, Todd served as Maintenance Manager, where he was deeply involved in navigating a consent decree and implementing corrective and preventive actions (CAPA), DMAIC, Six Sigma, and Lean methodologies to support long-term compliance and performance improvement.
Todd holds a Bachelor of Science in Electrical Systems from Southern Illinois University and is a certified Six Sigma Green Belt.

Todd Johnson

About Karl
With 19 years in recruitment, Karl is a seasoned professional known for connecting unique talents with the right roles.&nbsp;
His experience spans various regions including Europe, San Francisco, Dublin, and London - where he has recruited for global companies, established talent strategies, and specialised in sectors from hospitality to investment banking and now IT and Engineering.&nbsp;
Key to his success is his ability to actively listen, an approach that helps him understand clients' and candidates' needs. Passionate about tech advancements, he has built a vast network in IT and Engineering, maintaining respected relationships that drive his continued success in placing top talent in dynamic, evolving fields.
Outside of work, Karl is known for being heavily involved with various charities raising much needed funds for the local area and wild camping in beautiful Connemara or other parts of the coast of Ireland.

Karl Lippett

Gerard Cunniffe

Owen Clancy

Niall Finnerty

Tommy McKeown

About Gerard
With Sterling&rsquo;s expansion into Ireland &amp; Europe, Gerard joined the Sterling Engineering team in 2023. Gerard is a recruitment professional with over a decade of international experience in the Engineering and Construction sectors. Currently serving as the Recruitment Team Lead at Sterling Engineering , Gerard has been instrumental in driving talent acquisition strategies that align with the company&rsquo;s mission to provide exceptional project support and staffing solutions across various industries, including Life Sciences, Automation &amp; Robotics, Manufacturing, Tech, Food &amp; Beverage, and Construction.
His previous experience includes significant positions at 3D Personnel Ltd, LJB Recruit and Aspect Personnel. Gerard specialised in recruiting for key roles in the construction industry across Ireland, UK, Europe and Melbourne.&nbsp;
Gerard's known for building strong relationships with clients and candidates alike and is passionate about connecting top talent with leading organisations.
Outside of work, Gerard can be found at his local GAA pitch, running the roads or in his garden.
Education:
<ul>
<li>Bachelor of Business (Honours) from Institute of Technology, Sligo</li>
</ul>

Gerard Cunniffe 

About Robert
Robert Noble joined Sterling in 2012 following a 30 year distinguished career in the Pharmaceutical Sector. His role is to expand Sterling&rsquo;s engineering services offering and deepen support services to existing clients already engaged in this sector.
Robert was the former Director of Technology and Design Engineering for Abbott Labs&rsquo; Global Pharmaceutical Operations. He has chaired the Packaging Equipment for Pharmaceuticals (PEP) Industry Group for ten years and served on the Packaging Machinery Manufacturers Institute&rsquo;s (PMMI) Packaging Management Council for seven years. He is a graduate of the University of Illinois and has an MBA from Lake Forest Graduate School of Management.
Project Highlights:
Manorhamilton, Sligo, Ireland
<ul>
<li>Directed a cross-functional team to assess and select the location for a Potent Drug Manufacturing Facility, resulting in the selection of the Manor Hamilton site in Sligo, Ireland.</li>
<li>Developed comprehensive front-end planning, including site layout, equipment selection, and construction strategies for a greenfield plant.</li>
<li>Designed and oversaw the installation of a state-of-the-art potent tablet coater.</li>
<li>Oversaw the planning for the expansion of the plant to accommodate new product implementations.</li>
</ul>
&nbsp;
Sligo Medical Device Plant &amp; Irish Third-Party Medical Device Component Sites
<ul type="disc">
<li>Directed the manufacturability design of a combination product auto-injector, optimizing production efficiency and quality.</li>
<li>Managed a team responsible for coordinating third-party component manufacturing and final product assembly and packaging.</li>
</ul>
&nbsp;
Cork, Ireland
<ul type="disc">
<li>Managed a multi-plant team to transfer several product lines from Puerto Rico to the Cork facility.</li>
<li>Oversaw equipment procurement and modifications, technology transfer, and the regulatory approval process.</li>
</ul>
&nbsp;
Queensborough, UK
<ul type="disc">
<li>Identified and resolved a critical liquid manufacturing issue, preventing worldwide supply interruption for a life-saving pharmaceutical product.</li>
</ul>
&nbsp;
Ludwigshafen, Germany
<ul type="disc">
<li>Led the Capital Plan and execution of serialization/track-and-trace systems to meet global regulatory requirements.</li>
<li>Managed the selection and purchase of process equipment for a pharmaceutical extrusion suite.</li>
</ul>
&nbsp;
Campoverde, Italy
<ul type="disc">
<li>Executed Capital Plans for serialization/track-and-trace systems aligned with worldwide standards.</li>
<li>Directed the introduction of a new product, requiring the design and construction of a new production process suite.</li>
<li>Implemented packaging line automation and efficiency enhancements.</li>
</ul>
&nbsp;
Breda, Netherlands
<ul type="disc">
<li>Managed the development and implementation of packaging equipment for a greenfield high-rise automated warehouse.</li>
</ul>
&nbsp;
Singapore
<ul type="disc">
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; line-height: normal; mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;">
Oversaw the planning of a greenfield R&amp;D pharmaceutical facility, ensuring modern design and operational excellence.
</li>
</ul>
&nbsp;
Rio de Janeiro, Brazil
<ul type="disc">
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; line-height: normal; mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;">Directed the expansion of manufacturing and packaging capabilities to support the launch of a new product.</li>
</ul>
&nbsp;
Buenos Aires, Argentina
<ul type="disc">
<li>
Implemented automation projects to enhance the operational efficiency of the manufacturing site.
</li>
</ul>
&nbsp;
Membership organisations include:
<ul>
<li>
International Society of Pharmaceutical Engineers
</li>
</ul>

Robert Noble

About Donal
Donal O'Callaghan is a seasoned engineering professional with over 40 years of diverse experience in manufacturing, operations, engineering design, procurement, and construction. Since April 2023, he has acted as a Technical and Business Consultant with Sterling Engineering Ltd., where he focuses on driving sales and marketing initiatives, providing recruitment assistance, and overseeing the conceptual design of Life Sciences projects.
Prior to his role at Sterling, Donal co-founded Callaghan Engineering in 1990, leading the firm to become one of Ireland's premier multi-discipline consulting engineering companies. Under his leadership, Callaghan Engineering served over 200 clients, with more than 85% of sales derived from repeat business.
Throughout his career, Donal has held key positions in project management, with significant assignments in the biopharma and medical devices sectors. His commitment to engineering excellence and sustainability has driven his ongoing success in the industry. He has also acted as a Senior Inspector with An Bord Pleanala, mainly in the area of air/water pollution appeals.
Project Highlights:
<ul>
<li>Merck, Co. Cork: Project Manager for a &euro;36 million Media Manufacturing Plant and a $75 million membrane manufacturing facility.</li>
<li>Pfizer, Little Island: Oversaw a &euro;4 million Centrifuge Project and a &euro;1.5 million Front End Study.</li>
<li>Abbott Diagnostics, Longford: Directed a &euro;13.5 million facility upgrade in diagnostics.</li>
<li>Data Centre Facility, Dublin: Managed a &euro;55 million investment for a confidential client.</li>
<li>Amgen, Co. Dublin: Led a &euro;25 million Containment Project.</li>
<li>EU Presidency: Led an engineering team for Ireland&rsquo;s last Presidency of the EU, providing facilities for the print and broadcast media</li>
</ul>
Education &amp; Qualifications:
<ul>
<li>B.E. in Chemical Engineering, University College Dublin</li>
<li>Diploma in Project Management, University of Dublin</li>
<li>Member of The Institute of Directors (M.Inst.D)</li>
<li>Member of the International Society of Pharmaceutical Engineering (M.ISPE)</li>
<li>Chartered Engineer (CEng)</li>
<li>Fellow of Engineers Ireland (F.I.E.I)</li>
<li>Fellow of the Institution of Chemical Engineers (FIChemE)&nbsp;</li>
</ul>

Donal O'Callaghan

About Tim
Tim Silkaitis joined Sterling Engineering in 1992 as an Accounting Clerk. In 1997, he was promoted to an Accounting Manager and then in 2006 to Controller. As VP of Finance, he oversees all financial matters &mdash; including P &amp; L, 401(k), payroll services, and health insurance.
Tim is responsible for legal and contract administration and has IT department oversight.
Education:&nbsp;
<ul>
<li>Bachelors of Science Degree from Elmhurst College</li>
<li>MBA from DePaul University.</li>
</ul>

Tim Silkaitis

About Mark
Mr. Howard has extensive experience owning and operating two successful start-ups through sale. One acquirer was Waterlogic Plc, a publicly traded company on the AIM Exchange in London. Post acquisition he stayed on as Vice President of Sales and was part of the mergers and acquisitions team. 
Since joining Sterling Engineering in 2012 he has been a valuable contributor with progressive leadership roles primarily focused on our Life Science business vertical as well as in Sales and Operational leadership across the Technology, Health/Wellness, Facility, Manufacturing, and Engineering sectors.&nbsp; 
Mr. Howard was part of the tactical team sent to evaluate expanding Sterling Engineering&rsquo;s operations to Europe in 2019. As Senior Executive Vice President, Mr. Howard oversees operations for the Engineering Services Company and our European entity officed in Ireland.
Positions held: Sales Representative, Business Development Manager, Branch Sales Manager, Regional Manager, National Vice President of Sales, President/CEO.
Mark is proud to be a member of the&nbsp;<a href="https://diversityallianceforscience.com/">Diversity Alliance for Science</a>.

Mark Howard

About Dolores
Ms. Connolly is one of thirteen children born and raised to entrepreneurial parents in Co. Longford. She attended Loreto Convent in Mullingar, Co Westmeath and a certificate in childhood education from Association Montessori Internationale in London. In 1979 she was recruited to work for Alquin Montessori just outside of Chicago, Illinois.
Dolores appetite for business called when she left education and joined Danka Corporation, a global technology company. Over a 15-year career there she worked herself up the ranks to become Regional Vice President for Sales &amp; Services prior to joining Sterling Engineering and her husband, founder, Dan Casey.
She made an immediate impact in the business and worked her way up to the role of CEO at Sterling Engineering in 1997, a position she holds to this day. With 500+ employees, under Dolores&rsquo; tenure the business has grown by over 70% from when she started with annual revenues greater than &euro;50 million euros.
Dolores and Dan both being natives of Europe decided to open their EMEA Headquarters for Sterling Engineering in Ireland, with locations in Dublin and Galway. This new venture is driven by Sterling&rsquo;s global client demands to expand our world class service beyond North America. Ireland was a natural choice for Sterling&rsquo;s expansion plans.
Their partnership has not only highlighted success in business put is rich in philanthropic pursuits. For Dolores this started at an early age with the Simon Community (an Irish based organisation for the homeless) and the Prison Outreach Program in Ireland. Today, Dolores&rsquo; civic duty is primarily focused on STEM education initiatives and efforts prioritizing breaking the cycle of poverty, in particular for women and girls at a local and global level.&nbsp;
Dolores is proudly involved and an active member in several organisations:
<ul>
<li style="list-style-type: none;">
<ul type="disc">
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;"><a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.concernusa.org%2f&amp;c=E,1,bZUYdPL8X90Kqx6uRBfEMP9kHpApjqWdq5NbHqEs-pLLJ7TV7sgvudphsSRhE0ojdkdaHyIDnWNeqUGzllNp_jT3CrC-4SUjUr4HDOxW&amp;typo=1">Concern Worldwide</a> Executive Board Member since 1996</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;"><a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fiwfchicago.org%2f&amp;c=E,1,zVJrb3T0JX6gbfCKZE1ZytCmwErtOZnCLzzzuNL8tKYU62FIdhEITmKAsA_reyb2l75aBBD4nJpPTnmYh_63R_2ySjlTEnkNh_D9iKyg0ytC_vbOyhs,&amp;typo=1">International Women&rsquo;s Forum</a> Chicago, USA. Member since&nbsp;1998</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;">Chicago - Galway Sister Cities Committee, Member since 2022</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;">Chicago Council on Global Affairs,Presidents Circle, USA. Member since&nbsp;2001</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;"><a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.chicago.gov%2fcity%2fen%2fdepts%2fdps%2fprovdrs%2fcert%2fsvcs%2fminority_and_womenownedbusinessenterprisecertificationmbewbe.html&amp;c=E,1,FveUp8msoaGG90SRvLRtpSGGot8pua9OLDIZNsmZR5UBitjfXFNw-cjKHZcVDGcCNdI1rBSIYka_4QzDrk0D4Y1fVrLpKo8vQDsO3mdvY1Pht9RZ1GCEpQ,,&amp;typo=1">WMBE Chicago&nbsp;</a> USA. WBE &nbsp;Member since&nbsp;2013</li>
<li class="MsoNormal" style="color: #ffffff;">Irish Books, Arts and Music (iBAM!) Award, Person of the Year, 2018</li>
<li class="MsoNormal" style="color: #ffffff;">Chicago Mother Jones Statue Committee 2021</li>
</ul>
</li>
</ul>

R&D Design Engineer

Tommy McKeown

R&D Design Engineer

Business Project Manager

C&Q Engineer

Head of manufacturing

Engineering Technician

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