C&Q Lead Engineer, Biopharma Utilities & Start-Up

CAI; Limerick; On-site; EUR 130,000 - 180,000; Full time

Job summary

CAI is seeking a C&Q Lead in Limerick to direct commissioning, qualification, and startup of utility systems on a regulated biopharma project. You will drive system readiness, ensure GMP/GEP compliance, coordinate with Emerson, Vendors, Utilities, and Regeneron quality/validation, and hand over to operations.

This role also involves mentoring on-site engineers and leading technical decisions. The ideal candidate has 10+ years C&Q experience in pharma manufacturing and a proven track record

Qualifications

• 10+ years C&Q in regulated biopharma or pharma manufacturing.
• Led C&Q programs for multi-system, large-scale facilities.
• Experience coordinating schedules across multiple workstreams and vendors.
• Strong knowledge of WFI, utilities, and process systems.

Responsibilities

• Lead and oversee all C&Q activities in active collaboration with the 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.
• Ensure activities comply with GEP (pre-GMP) and GMP (qualification) standards.
• Manage C&Q resources for applicable systems.
• Coordinate with Emerson, Vendors, Utilities team, and Regeneron quality/validation.
• Support system handover to operations; ensure issues resolved and systems meet requirements.
• Provide guidance and mentorship to other C&Q engineers.

Skills

C&Q Leadership

Regulated Biopharma

Project Scheduling

Vendor Coordination

GMP/GEP

ValGenesis (qualification system)

Tools

Emerson Automation

P&IDs

Documentation management

Process control systems

Job description

CAI is seeking a C&Q Lead in Limerick to direct commissioning, qualification, and startup of utility systems on a regulated biopharma project. You will drive system readiness, ensure GMP/GEP compliance, coordinate with Emerson, Vendors, Utilities, and Regeneron quality/validation, and hand over to operations.

This role also involves mentoring on-site engineers and leading technical decisions. The ideal candidate has 10+ years C&Q experience in pharma manufacturing and a proven track record