Validation Engineer

5 days ago

Cork, Ireland Hw3 Full time

Are you an experienced Commissioning & Qualification (CQV) professional?
Do you have a proven background delivering qualification and commissioning documentation for critical pharmaceutical systems?
Are you looking for a role where you can take ownership of qualification deliverables on direct impact systems and support commissioning of utilities and equipment in a fast-paced GMP environment?
We are seeking a
CQV Engineer
to support a pharmaceutical manufacturing programme on a long-term contract.
The successful candidate will be responsible for generating, executing, and approving qualification documents, as well as developing commissioning test documentation for non-direct impact systems.
Key Responsibilities
Generation, execution, and approval of qualification documents for facility, utility, and equipment (direct impact systems).
Preparation of commissioning test documentation for non-direct systems.
Support clean utility tie-ins to existing systems (e.g., upgrading purified water skids to support new tanks).
Work across equipment such as dispensing systems (downflow booths, Matcom stations, PTS powder systems), tumble mixers with CIP skids, and utilities including compressed air.
Apply a risk-based approach to commissioning and qualification activities, ensuring adherence to cGMP and cGDP.
Collaborate with engineering, operations, and quality teams to deliver validated systems on time.
Requirements
BS degree in Engineering, Science, or related technical discipline.
Minimum 3 years' commissioning and qualification experience, ideally in OSD or pharmaceutical environments.
Previous experience with clean utilities.
Strong technical writing skills with a proven ability to produce high-quality validation documentation.
Strong interpersonal and teamwork skills with flexibility to adapt to unexpected project demands.
Demonstrated experience working within fast-paced GMP environments.
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