CQV Engineer

Description:

PE Global is currently recruiting for a CQV Engineer on behalf of a leading API company based in Cork. This is an initial 6-month contract role.

Responsibilities:

• Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
• Prepare C&Q protocols as required (e.g. URS’s / SRS’s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
• Review and approve documents prepared by contractor organisations (e.g. vendor SAT’s, FAT’s, commissioning protocols, project change controls/notifications).
• C&Q System / Equipment / Components as per site procedures.

Education and Experience:

• Third level degree and relevant experience.
• Experience of commissioning and qualifying some of the following systems:
• Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
• Experience in cGMP regulated environment.
• Extensive experience of commissioning and qualification of systems, utilities and processes, and change management.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to [email protected]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***