CQV Engineer

Desired Skills: commissioning,qualification,validation,project management

Description:

PE Global is currently recruiting for a CQV Engineer on behalf of a leading pharmaceutical company based in Cork. This is an initial 12-month contract role.

Overview:

• As part of the Technical Compliance Team, this contract position is responsible for all activities required to support project commissioning and qualification.
• The role of the C&Q Engineer and associated activities include (but not limited to), the preparation and execution of commissioning and qualification protocols (where applicable) for site systems / equipment such as 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.).

Responsibilities:

• Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
• 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).
• Execute C&Q protocols as required.
• Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.
• Complete activities / deliverables in accordance with each project’s site change control required deliverables (from a C&Q perspective).
• Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
• Prioritize C&Q activities in line with site and project schedules.
• Co-ordinate C&Q activities with project engineering, construction and site operations activities.
• Co-ordinate C&Q activities with contractors and vendors as required.
• Co-ordinate C&Q document reviews and approvals.
• C&Q System / Equipment / Components as per site procedures.
• Strong collaboration with Quality Department.

Education and Experience:

• Third level degree and relevant experience.
• Minimum 5+ years’ experience in the Pharmaceutical (API) Industry.
• 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 preparing and executing commissioning and qualification protocols and reports.
• Experience in cGMP regulated environment.
• Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.
• Knowledge and experience of Project Delivery Processes (PDP).
• Knowledge and experience of current Good Engineering Practices (GEP).
• Experience with use of ABB Industrial IT control systems.
• Experience of Pharmaceutical facility local and controlling instrumentation
• Experience of working within a Technical Compliance / Project team in a multinational corporate environment.
• Experience of ASTM 2500 and/or Risk Based Qualification approach.

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 kellie.hackett@peglobal.net

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