Packaging Engineer TPM6072

Summary:

Our client, a leading biopharmaceutical company based in West Dublin, is seeking an experienced Packaging Engineer to lead the technical delivery of a major capital investment project involving the installation of two new packaging lines. The successful candidate will provide technical leadership throughout the project lifecycle, ensuring both the Device Assembly Line and Finished Product Packaging Line are designed, procured, installed and commissioned in accordance with the company's approved User Requirement Specifications (URS), site engineering standards and regulatory requirements. The role requires extensive capital project and packaging engineering experience within a GMP-regulated pharmaceutical or biopharmaceutical environment.

Responsibilities:

• Lead the technical delivery of two new packaging lines, comprising a Device Assembly Line and a Finished Product Packaging Line.
• Act as the client facing lead throughout the project lifecycle, from detailed design through procurement, factory acceptance testing (FAT), site acceptance testing (SAT), installation, commissioning, qualification and operational handover.
• Ensure all equipment is delivered in accordance with approved User Requirement Specifications (URS), site engineering standards and project objectives.
• Provide technical leadership to the project engineering team, contractors, system integrators and equipment vendors.
• Review and approve engineering deliverables including equipment specifications, layouts, P&IDs, functional design specifications and vendor documentation.
• Lead technical design reviews, risk assessments, HAZOPs/FMEAs and change control activities.
• Coordinate closely with Manufacturing, Operations, Quality, Validation, Automation, Supply Chain and Maintenance teams to ensure successful project execution.
• Support procurement activities, including technical bid evaluations and vendor selection.
• Oversee FATs and SATs to ensure equipment meets performance, quality and regulatory requirements.
• Ensure commissioning and qualification activities (IQ/OQ/PQ) are completed in accordance with GMP and site validation procedures.
• Manage technical risks and proactively resolve engineering issues to maintain project schedule and budget.
• Ensure compliance with EHS policies, cGMP requirements and applicable regulatory standards throughout project execution.
• Support project planning, reporting and governance, providing regular technical updates to senior project stakeholders.
• Drive continuous improvement and identify opportunities to optimise packaging processes, equipment reliability and operational efficiency.

Qualifications & Experience:

• Bachelor's Degree in Mechanical, Manufacturing, Chemical, Process or Electrical Engineering, or a related engineering discipline.
• 10-15 years' engineering experience within the pharmaceutical, biopharmaceutical or medical device industry.
• Significant experience delivering large-scale capital projects within GMP-regulated manufacturing environments.
• Proven experience leading the delivery of automated packaging lines or high-speed manufacturing equipment.
• Strong understanding of packaging technologies, including device assembly, secondary packaging, inspection systems, labelling, cartoning, case packing and serialization.
• Demonstrated experience managing equipment suppliers, EPCM partners and multidisciplinary engineering teams.
• Extensive knowledge of commissioning, qualification and validation processes (IQ/OQ/PQ).
• Thorough understanding of cGMP, FDA, EMA and EU GMP requirements.
• Experience reviewing and developing User Requirement Specifications (URS), Functional Specifications (FS), Design Qualification (DQ) documentation and technical engineering documentation.
• Strong knowledge of project delivery methodologies and engineering governance for capital projects.
• Excellent leadership, communication and stakeholder management skills.
• Ability to influence cross-functional teams and manage multiple technical workstreams simultaneously.
• Experience working on projects valued in excess of €20 million, ideally including packaging or fill-finish facilities, would be highly advantageous.
• PMP, PRINCE2 or equivalent project management qualification would be an advantage.