Senior C&Q Engineer – Ref. MQ215

  • Contract
  • Carlow

Website HeadcountGroup Headcount Solutions

Senior C&Q Engineer

Headcount Solutions is seeking a C&Q Engineer for our multinational client’s biotech facility.

The successful candidate will be able to demonstrate a proven track record to take systems from the Design Phase through Construction Handover stage and carry them through the Commissioning and Validation cycle to allow handover to Manufacturing.

This person will be required to have an understanding of digital execution methods (ie. KNEAT) for digital execution of C&Q lifecycle deliverables.

Main Responsibilities:

  • Lead and coordinate a commissioning and qualification program for Drug Product formulation and filling, clean and black utilities, support services, and laboratory equipment.
  • Lead the planning and tracking of activities, working with the assigned C&Q partner.
  • Owner of pre-requisite C&Q Strategy and deliverables (System Level Impact Assessment, Component Level Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
  • Oversees the generation, execution and approval of C&Q documentation in electronic format in KNEAT (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
  • Generate C&Q change controls (FPIDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
  • Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
  • Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion

Requirements:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 8 years’ experience in commissioning and/or validation of Drug Product/Facilities/Utilities systems within the Pharmaceutical industry.
  • Technical knowledge of utilities, filling and formulation equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
  • Minimum 5 years of experience with supervisory, project management and budget management are required.

For further information, please contact Mick on 00353-86-0435195 or forward details in confidence to jobs@headcount.ie

 

 

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