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Angela McCauley
Life Science

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[email protected]
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Details

Commisioning and Qualification Engineer


Reference:AM0058 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Project 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.

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.
Apply today or get in touch with Angela McCauley at Life Science recruitment for more info on this and similar roles.