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Commisioning and Qualification Engineer
Reference: | AM0058 | Location: |
Cork |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
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.
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 / 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).
Following would be an advantage,
- 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.
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