We are currently seeking an experienced CQV Engineer to join a dynamic and high-performing CQV team supporting a Sterile Drug Product (SDP) facility in Dublin. The successful candidate will lead Commissioning, Qualification & Validation (CQV) activities for component preparation systems, including autoclaves, part washers, single-use mixers, utility panels, and more.
A key part of this role will involve Factory Acceptance Testing (FAT) for new equipment, with EU travel expected from September 2025 onward. This is a fully onsite position that offers an exciting opportunity to contribute to the successful delivery of a complex pharmaceutical project from an early stage.
Key Responsibilities:
- Plan and execute CQV testing for component prep equipment and black utility systems
- Prepare, review, and execute CQV documentation, including commissioning protocols, IQ/OQ, and FAT documentation
- Support and attend FATs at vendor sites in Europe
- Drive documentation through to closure in a timely, quality-focused manner
- Ensure testing is conducted in compliance with GMP, FDA, and EU regulations
- Lead and/or support risk assessments, deviation resolution, and ensure robust documentation practices
- Act as a CQV Area Lead Designee when required
- Ensure training compliance in line with site metrics
Key Systems Covered:
- Autoclaves
- Parts Washers
- Single-Use Mixers & TCUs
- Utility Panels & Filtration Systems (e.g. TFF)
- Powder Handling Equipment (e.g. Jet Mills, Blenders)
- Black Utilities (Chilled Water, Compressed Air, Drainage, etc.)
Qualifications & Experience:
- Minimum Level 8 / Bachelor's degree in Engineering, Science, or related technical discipline
- 5-10 years of CQV experience in the pharmaceutical/biotech sector, ideally in sterile manufacturing environments
- Proven expertise with component preparation systems and utility-based equipment
- Experience in document generation and execution across all CQV phases, including FAT, commissioning, and qualification
- Solid understanding of GMP requirements and regulatory expectations
- Prior experience in equipment FAT support and willingness to travel within the EU is essential
- Excellent planning, problem-solving, and communication skills
- Comfortable working in a fast-paced environment with a team-oriented mindset
