C&Q Lead Engineer – Biopharma GMP Readiness

Commissioning Agents Inc (CAI); Limerick; On-site; EUR 90,000 - 130,000; Full time

Job summary

CAI in Limerick is seeking a C&Q Lead to direct commissioning, qualification, and startup activities for utility systems within regulated biopharma projects. You will drive system readiness and ensure GMP compliance, guiding handover from construction through to operations.

The role requires leading cross-functional teams, coordinating with vendors and on-site teams, and mentoring other C&Q engineers to uphold high standards.

Qualifications

• 10+ years C&Q in a regulated biopharma or pharmaceutical manufacturing environment.
• Demonstrated track record leading C&Q programmes for multi-system large-scale bioprocess facilities.
• Experience managing integrated schedule co-ordination across multiple workstreams and vendors.

Responsibilities

• Lead and oversee all C&Q activities in active collaboration with the incumbent on-site C&Q Lead.
• Serve as the primary escalation point for troubleshooting and resolution of technical issues.
• Conduct system walkdowns and readiness reviews; verify systems are ready for Commissioning commencement.
• Ensure all activities comply with GEP (pre-GMP) and GMP (qualification) standards throughout.
• Manage the C&Q resources for applicable systems.
• Co-ordinate with Emerson Automation, Vendors, Utilities team, and Regeneron quality/validation.
• Support system handover to operations; ensure all issues resolved and systems meet operational requirements.
• Provide guidance and mentorship to other C&Q engineers within the team.

Skills

C&Q Leadership

Regulated Biopharma

Schedule Coordination

Tools

P&IDs

ValGenesis

DCS/PLC

Job description

CAI in Limerick is seeking a C&Q Lead to direct commissioning, qualification, and startup activities for utility systems within regulated biopharma projects. You will drive system readiness and ensure GMP compliance, guiding handover from construction through to operations.

The role requires leading cross-functional teams, coordinating with vendors and on-site teams, and mentoring other C&Q engineers to uphold high standards.