Project Engineer

As Project Engineer, you will provide engineering support to maximise the availability, reliability and performance of site process equipment and utilities.You will manage and deliver capital engineering projects, typically up to approximately €5 million, while supporting continuous improvement, process engineering, troubleshooting and process safety initiatives across the site.

You will work closely with Production, Engineering, Quality, Operations, contractors and external engineering partners to ensure projects and improvements are delivered safely, on schedule, within budget and to the required GMP and quality standards.

Key Responsibilities

• Manage capital engineering projects from concept and feasibility through design, procurement, installation, commissioning, qualification and handover.
• Deliver projects in accordance with established pharmaceutical project lifecycle processes.
• Prepare feasibility studies, project scopes, cost estimates, budgets and project plans.
• Specify, design and install new process equipment, utilities and manufacturing systems.
• Lead equipment commissioning and Commissioning & Qualification (C&Q) activities.
• Support facility and cleanroom construction, commissioning and qualification activities.
• Manage the installation and C&Q of clean and black utilities.
• Provide process engineering and technical troubleshooting support within a live manufacturing environment.
• Identify and implement continuous improvement and reliability initiatives.
• Work closely with Production to maximise equipment uptime, reliability and process performance.
• Support process safety projects and wider site process safety initiatives.
• Manage contractors, external engineering personnel and suppliers, including contract negotiation and performance management.
• Liaise with internal and external engineering teams during equipment installation, commissioning and troubleshooting.
• Support change control activities associated with engineering projects and process modifications.
• Ensure projects are delivered in compliance with cGMP, regulatory, safety and quality requirements.
• Support major site initiatives and contribute to the achievement of wider site goals.
• Identify opportunities to improve equipment reliability, process efficiency and operational performance.

Essential Experience & Qualifications

• A degree in Mechanical, Chemical, Process Engineering or a related engineering discipline.
• 5+ years' experience in a pharmaceutical manufacturing/site engineering environment.
• Strong experience within OSD (Oral Solid Dose) and/or API manufacturing.
• Proven experience delivering pharmaceutical capital projects from cradle to handover.
• Experience working within a large pharmaceutical, biotech or engineering services organisation.
• Strong experience with equipment specification, design, installation, commissioning and qualification.
• Experience with C&Q and change control processes.
• Experience delivering projects involving manufacturing equipment, facilities and/or utilities.
• Strong understanding of cGMP and pharmaceutical regulatory requirements.
• Proven project management capability, including delivery to schedule, budget, quality and safety requirements.
• Strong process engineering and troubleshooting capability within a live manufacturing environment.
• Experience with batch processing and manufacturing systems.
• Experience working with contractors and external engineering providers.
• A structured and logical approach to problem solving, with the ability to work hands-on and respond effectively to day-to-day engineering issues.

Relevant Technical Experience

Candidates should have demonstrated site experience with one or more of the following areas:

• OSD / Drug Product Equipment
• API Manufacturing
• Downflow booths and containment systems
• Facilities & Utilities
• Cleanroom facilities
• HVAC systems
• CIP systems
• Clean and black utilities
• Pharmaceutical manufacturing infrastructure
• Automation & Controls
• Working knowledge of distributed control systems, ideally DeltaV.
• Understanding of automation associated with pharmaceutical process equipment.

Desirable Experience

The following would be advantageous:

• Experience with TrackWise change control.
• Electrical engineering experience, including electrical system design and installation.
• Experience with process equipment and site electrical infrastructure.
• Knowledge of ATEX regulations and requirements.
• Experience supporting process safety projects.
• Experience in equipment reliability and continuous improvement programmes.

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