CQV Engineer

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