Jobs at CAI (Now Hiring) — 3 open

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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.

Key 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.

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.

Technical Skills

• 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).

 

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