We are seeking a high-caliber Commissioning & Qualification (C&Q) Engineer to join a major capital project team at a world-class pharmaceutical manufacturing facility in Cork. The successful candidate will take ownership of the CQV lifecycle for complex process systems, ensuring equipment and utilities meet stringent global regulatory standards.
This role is ideal for a self-starting engineer with a deep background in DeltaV automation and modern paperless validation workflows.
Key Responsibilities
- Project Lifecycle Management: Lead CQV packages from design through to final handover, managing multiple workstreams simultaneously.
- Paperless Validation: Author and execute validation protocols (Traceability Matrices, CLIAs, IVs, OVs) using digital platforms such as Kneat.
- Process Systems Oversight: Manage C&Q for diverse systems, potentially including Solvent Storage, Tanker Unloading, Glycol systems, and Laboratory expansions.
- Technical Verification: Conduct field walkdowns against P&IDs and approve commissioning protocols pre- and post-execution.
- Automation Collaboration: Coordinate closely with Automation workstreams to qualify Emerson DeltaV integrated process systems.
- Compliance & Safety: Generate and drive Project Change Controls (PCCs), manage FAT/SAT closures, and lead Pre-Startup Safety Review (PSSR) meetings.
- Reporting: Deliver weekly progress, risk, and schedule updates to project leadership.
Candidate Requirements
- Experience: Minimum of 5 years' experience in a C&Q/CQV role within a GMP-regulated environment (Pharma/Biotech).
- Process Expertise: Proven track record working on Process Systems (e.g., Utilities, Solvent Handling, or Lab expansions).
- Automation: Practical experience with Emerson DeltaV is essential for this role.
- Documentation: Experience with paperless validation systems (Kneat) is highly advantageous.
- Communication: Ability to manage stakeholders effectively and drive project timelines in a fast-paced environment.
- Education: Degree in Engineering (Chemical, Mechanical, or Process) or a related scientific discipline.
