C&Q Lead Engineer

Cagents; Limerick; Hybrid; EUR 110,000 - 160,000; Full time

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 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.

Job Title: C&Q Lead

Location: Limerick

Contract Type: Staff or Contract

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).