Senior C&Q Lead Engineer - Biopharma Start-Up

Cagents

Limerick

Hybrid

EUR 110,000 - 160,000

Full time

2 days ago
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Job summary

CAI in Limerick seeks a C&Q Lead to direct commissioning, qualification, and startup of utility systems for a regulated biopharma project. You will drive system readiness, ensure GMP readiness, and guide the transition from construction to operational handover.

You will lead C&Q activities, coordinate with Emerson Automation and vendors, and mentor other engineers while ensuring compliance with regulatory standards and quality expectations.

Qualifications

  • 10+ years C&Q in regulated biopharma environment.
  • Led C&Q programmes for multi-system facilities.
  • Managed integrated schedule across multiple workstreams and vendors.
  • Strong knowledge of WFI, chilled water, and utilities.
  • Proficient with P&IDs, drawings, and specifications.
  • Experience with electronic qualification systems (ValGenesis preferred).

Responsibilities

  • Lead and oversee all C&Q activities with on-site lead.
  • Escalation point for troubleshooting technical issues.
  • Conduct system walkdowns and readiness reviews.
  • Ensure compliance with pre-GMP and GMP standards.
  • Coordinate with Emerson Automation, Vendors, Utilities, and Regeneron QA.
  • Support handover to operations after issues resolved.
  • Mentor other C&Q engineers.

Skills

C&Q leadership
Regulatory compliance
Schedule coordination
GMP knowledge
P&IDs knowledge
Automation systems
ValGenesis

Tools

Emerson Automation
DCS/PLC

Job description

CAI in Limerick seeks a C&Q Lead to direct commissioning, qualification, and startup of utility systems for a regulated biopharma project. You will drive system readiness, ensure GMP readiness, and guide the transition from construction to operational handover.

You will lead C&Q activities, coordinate with Emerson Automation and vendors, and mentor other engineers while ensuring compliance with regulatory standards and quality expectations.

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