Job Title: CQV Engineer
Location: Sligo
Department: Engineering
Level : Eng l or Eng ll
Reports To: CQV Manager
About the Role
We are seeking an experienced CQV Engineer to join our Engineering team. This is an exciting opportunity for a self-driven professional with strong pharmaceutical or biotechnology industry experience to lead Commissioning, Qualification and Validation (CQV) activities across facility, utility and process systems.
This role supports both new and legacy equipment and plays a critical part in ensuring compliance with GMP and regulatory standards.
Key Responsibilities
- Plan, generate, execute and report CQV activities including C&Q Planning, URS, DQ, FAT, SAT, IQ, OQ and PQ (as applicable).
- Prepare, review and approve project documentation in compliance with cGMP/GxP standards.
- Support design reviews, risk assessments and system walkdowns.
- Perform field verifications during static and functional testing.
- Coordinate vendor documentation review and site attendance.
- Liaise with Construction, QA, Operations and Project Teams to support Mechanical Completion and system handover.
- Manage CQV discrepancies and change controls.
- Participate in equipment startup and vendor FAT visits (including travel to mainland Europe where required).
- Support investigations into system anomalies and safety incidents.
Skills & Competencies
- Strong knowledge of GMP/GDP and industry regulatory standards
- Excellent written and verbal communication skills
- Strong stakeholder management and cross-functional collaboration ability
- High attention to detail and quality focus
- Ability to work independently in a fast-paced project environment
Essential Requirements
- Honours Degree in Engineering or Science
- Minimum 3 years’ CQV experience within biotechnology and/or pharmaceutical industry
- Proven experience authoring, reviewing and executing CQV documentation for facilities, utilities and process equipment
Desirable Experience
- Clean utilities and aseptic processing facilities
- Computer Systems Validation (CSV)
- Temperature mapping and sterilisation cycle validation
If you are a motivated CQV professional looking to contribute to high-impact pharmaceutical projects, we would love to hear from you.
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For a confidential discussion and more information on the role, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie
071 9140251
