Lead Packaging Engineer, GMP Capital Project (Two Lines)

Tandem Project Management Ltd.; Dublin; On-site; EUR 110,000 - 140,000; Full time

Job summary

Tandem Project Management Ltd. in West Dublin is seeking an experienced Packaging Engineer to lead the technical delivery of two new packaging lines, a Device Assembly Line and a Finished Product Packaging Line.

You will oversee design, procurement, FAT/SAT, installation and commissioning in line with URS and regulatory standards. The role requires extensive capital project and packaging engineering experience in GMP-regulated environments, with a focus on device assembly, secondary packaging,

Qualifications

• Bachelor's degree in engineering with GMP/regulatory exposure.
• 10–15 years' pharmaceutical/biopharma capital projects experience.
• Experience delivering automated packaging lines or high-speed equipment.
• Knowledge of URS, FS, DQ documents and QA/GMP processes.
• Experience managing suppliers, EPCM partners and engineering teams.
• Experience reviewing commissioning/validation (IQ/OQ/PQ).
• Knowledge of cGMP, FDA/EMA/EU GMP requirements.

Responsibilities

• Lead technical delivery of two packaging lines (Device Assembly and Finished Product).
• Act as client-facing lead across design, procurement, FAT, SAT, installation and handover.
• Ensure equipment meets URS, site standards and project objectives.
• Provide senior technical leadership to project teams and vendors.
• Review equipment specs, P&IDs and vendor documentation.
• Lead design reviews, risk assessments, HAZOPs/FMEAs and change control.
• Coordinate with Manufacturing, Quality, Validation, Automation and Maintenance.
• Support procurement through technical evaluations and vendor selection.
• Oversee FATs/SATs and commissioning activities (IQ/OQ/PQ).
• Manage technical risks and keep schedule and budget on track.
• Ensure compliance with EHS, cGMP and regulatory standards.
• Provide regular technical updates to senior stakeholders.

Skills

Project leadership

Regulatory compliance

GMP knowledge

Vendor management

Cross-functional coordination

Risk assessment

Education

Bachelor's Degree in Mechanical, Manufacturing, Chemical, Process or Electrical Engineering

Job description

Tandem Project Management Ltd. in West Dublin is seeking an experienced Packaging Engineer to lead the technical delivery of two new packaging lines, a Device Assembly Line and a Finished Product Packaging Line.

You will oversee design, procurement, FAT/SAT, installation and commissioning in line with URS and regulatory standards. The role requires extensive capital project and packaging engineering experience in GMP-regulated environments, with a focus on device assembly, secondary packaging,