Lead Commissioning, Qualification & Validation (CQV) Engineer
We are seeking an experienced CQV engineer to lead Commissioning, Qualification & Validation activities for component preparation systems in a Sterile Drug Product facility.
The successful candidate will be responsible for planning and executing CQV testing for component prep equipment and black utility systems. This includes preparing, reviewing, and executing CQV documentation, such as commissioning protocols, IQ/OQ, and FAT documentation.
* Plan and execute CQV testing for component prep equipment and black utility systems.
* Prepare, review, and execute CQV 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.
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:
1. CQV Area Lead Designee when required.
2. Act as a key member of the CQV team supporting a Sterile Drug Product facility.
A strong understanding of GMP requirements and regulatory expectations is essential for this role. Prior experience in equipment FAT support and willingness to travel within the EU is also required.
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.
* Solid understanding of GMP requirements and regulatory expectations.
* Prior experience in equipment FAT support and willingness to travel within the EU.