Commisioning and Qualification Engineer

Biotech - Cork
C&Q Engineer
12 month contract
On site - Cork

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, the preparation and execution of commissioning and qualification protocols for site systems / equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / grey utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).

The ideal candidate would have 5+ years experience in API industry including several years working in Commissioning and Qualification of equipment

Job 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 SATs, FATs, 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 projects 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.

• 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 / grey 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.
• 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
• Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.
• Experience of working within a Technical Compliance / Project team in a multinational corporate environment
• Experience of ASTM 2500 and/or Risk Based Qualification approach.