Inspection CQV Engineer – Sterile Drug Product Facility
Duration:
12 Months
Location:
Cruiserath, Dublin
Working hours:
39 per week
Onsite requirements:
Onsite
Engagement Type:
LTD Company Contractor
Day Rate:
Up to €80/hour (DoE)
Atrium Global
is supporting a leading pharmaceutical client in their search for an experienced
CQV (Commissioning, Qualification & Validation) Engineer
to support the commissioning and qualification of Inspection Systems at their Sterile Drug Product manufacturing facility.
Job Overview
The successful candidate will work closely with the CQV Area Lead and cross-functional project teams to deliver critical project milestones in alignment with GMP, FDA, EU regulations, and company procedures. This role requires strong expertise in the CQV lifecycle, with specific experience in sterile drug product inspection systems.
RESPONSIBILITIES
* Develop and execute CQV protocols (FAT/SAT/IOQ) for automated and manual inspection equipment, including Syringe and Vial Visual Inspection Systems.
* Ensure compliance with GMP, FDA/EU regulations, and internal standards during all CQV activities.
* Drive safety, quality, and schedule adherence across assigned deliverables.
* Manage deviations, implement corrective actions, and support risk assessments.
* Integrate FAT results into qualification strategy and documentation.
* Maintain training compliance in accordance with site metrics and project timelines.
REQUIREMENTS
* Proven experience across the full CQV lifecycle – from design to handover.
* Expertise in sterile drug product equipment, ideally visual inspection systems.
* Strong track record in FAT execution and management.
* Excellent documentation and task planning skills with a focus on timely delivery.
* Experience with electronic validation platforms (e.g. ValGenesis, Kneat).
* Effective communication and collaboration skills within matrix project environments.
* Familiarity with risk management and deviation handling in GMP settings.
* Bachelor's degree in Engineering, Science, or a related technical discipline.
* Minimum of 5 years' experience within the pharmaceutical industry, ideally with sterile drug product and inspection systems.
* Previous CQV experience in GMP manufacturing is essential.
Legal right to work:
Candidates must have the legal right to work in Ireland. Sponsorship is not available for this role.