C&Q Lead Engineer Utilities

CAI • Limerick, PA

3d • Onsite

About The Position

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. The C&Q Lead will be accountable for directing the commissioning, qualification, and start-up (shakedown) of utility systems within a regulated biopharmaceutical project. The successful candidate will drive system readiness, ensure compliance with regulatory standards, and lead the transition from construction completion through to operational handover.

Requirements

• 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.
• Strong knowledge of Cleans and Grey utilities/Facilities WFI, Chilled Water Systems, etc.
• Proficiency in P&IDs, engineering drawings, functional design specifications, and technical documentation.
• Experience with process control and automation platforms, particularly distributed control systems and PLC-based architectures.
• Demonstrated understanding of electronic qualification systems (ValGenesis preferred).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed