Project Manager

Project Manager – Sterling Engineering
 
The role will involve managing a number of client-based projects involving design, construction, commissioning, and handover.

The role will primarily involve conceptual and detailed design support and co-ordination & project management, project budget and schedule management, project resource and contractor management, equipment procurement, interfacing with clients Maintenance, Automation, EHS, Quality, and Operations Depts or third party suppliers. 

Responsibilities will include:
 

• Manage all phases of projects from concept through to implementation and close-out. Manage the design, construction, commissioning and qualification, project schedule, and cost.
• Maintain a strong safety culture and performance in the implementation of projects.
• Ensure successful delivery of projects which meet business needs. Deliver cost-effective projects in line with our project management procedures and best practices.
• Ensuring that projects and programs are proceeding according to scope, schedule, and quality standards
• Developing and maintaining collaborative relationships with stakeholders.
• Identify effective & innovative engineering design solutions which meet project client/end user requirements.
• Plan and lead the delivery of projects which meet all regulatory requirements including safety, quality, and environmental requirements.
• Ensure that equipment qualification activities are completed in line with local client procedures, cGMP, and best practices.
• Generate and manage project schedules to plan and track project activities over the life-cycle of the project.
• Manage project risk registers with appropriate monitoring and tracking of mitigation actions agreed.
• Manage multi-discipline project stakeholder input as required for successful project delivery
• Supporting the professional services aspect of the business to ensure the staffing and recruitment team's needs are met.
• Executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Carrying out thorough Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at the vendor's or Clients facilities.

Experience Required:

• Excellent communication and organizational skills are required, with a proven ability to effectively engage with all levels of the organization.
• Ideally, candidates should have experience in a Drug substance API manufacturing site, which may include familiarity with piping systems, drying systems, HVAC, utilities, reactors, centrifuges, vacuum systems, abatement and heat/cooling systems. Alternatively, experience in a drug product fill/finish facility, covering compounding, isolators, filling, lyophilizers, vision inspection systems, as well as packaging and labelling technology, is also valuable. A strong knowledge of medical device manufacturing would be a bonus and also considered.
• Understanding of Clean and Black Utilities requirements.
• Strong process engineering experience.
• Experience in the design of automated equipment.
• Recognised Qualification or Certification in Project Management is preferred
• Familiarity with Front-End Studies (FES), detailed engineering, RFP’s, tender packages, and collaboration with design offices is important.
• Proven experience in consulting, program/project management, business process management and improvement, gained from working within life sciences Pharma, Biologic’s or Medical Device industry.
• Working knowledge of regulatory requirements (e.g. EU MDR, FDA, etc.) and their impact on Quality Management Systems and associated processes is a plus.
• Understanding validation processes and executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience carrying out thorough Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at the vendor's or Clients facilities to ensure that all equipment and systems meet the required specifications and performance standards before they are deployed to the operational site.
• Confirmed ability to get results through leading others, organising, prioritising, and delegating workload is required

Minimum Requirements:

• Candidates should hold at minimum a bachelor’s degree in Engineering (Mechanical, Chemical, Process) and at least 5 to 7 years of project management experience in the Pharmaceutical industry or Medical Device Industry.