Packaging Engineer TPM6072

Tandem Project Management Ltd.; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Tandem Project Management Ltd. is seeking an experienced Packaging Engineer to lead the technical delivery of a major capital investment project in West Dublin, overseeing two new packaging lines and ensuring URS, GMP and regulatory alignment throughout the lifecycle.

The role requires 10-15 years of packaging/engineering experience in GMP environments, proven leadership of large-scale packaging projects, and strong collaboration with Manufacturing, Quality, Validation and Maintenance teams.

Qualifications

• Bachelor’s degree in an engineering discipline related to manufacturing/packaging.
• 10-15 years of engineering experience in pharmaceutical/biopharmaceutical or medical device industries.
• Proven experience delivering large-scale GMP projects with automated packaging lines or high-speed equipment.
• Strong knowledge of packaging technologies including device assembly, packaging, labeling, serialization.
• Experience leading multiple engineering teams and coordinating with suppliers/EPCM partners.

Responsibilities

• Lead the technical delivery of two new packaging lines (Device Assembly Line and Finished Product Packaging Line).
• Act as client-facing lead through design, procurement, FAT, SAT, installation, commissioning and handover.
• Ensure equipment meets URS, site standards, GMP and regulatory requirements.
• Provide leadership to project engineering teams, contractors and vendors.
• Manage design reviews, risk assessments, HAZOPs/FMEAs, and change control activities.
• Coordinate with Manufacturing, Operations, Quality, Validation, Automation and Maintenance to drive project execution.
• Support procurement activities including technical bid evaluations and vendor selection.
• Oversee FATs and SATs to ensure performance and regulatory compliance.
• Ensure IQ/OQ/PQ commissioning and qualification activities are completed per GMP procedures.
• Mitigate technical risks and maintain schedule/budget.
• Comply with EHS policies and regulatory standards throughout project execution.
• Prepare governance updates for senior stakeholders.
• Identify opportunities to improve packaging processes and equipment reliability.

Skills

Leadership

Stakeholder management

Cross-functional collaboration

Communication

Risk management

Project planning

Education

Bachelor’s Degree in Mechanical/ Manufacturing/ Chemical/ Process or Electrical Engineering

Tools

URS

FS

DQ documentation

Job description

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.