CSV Engineer

CSV Engineer, Biotech Company, Annual Bonus, Hertfordshire

Our biotech client with manufacturing facilities just outside London is currently investing significantly in their manufacturing program. This state-of-the-art facility houses high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. The site is easily reachable by two major airports and has excellent transport links throughout

The client is currently seeking the expertise of a CSV Engineer.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

• Site Subject Matter Expert for Computerized Systems Validation.
• Responsible for developing and managing the site strategy towards CSV.
• Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
• Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
• Support vendors to ensure adherence to and application of GAMP is aligned with BPL expectation.
• Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
• Work cross-functionally to ensure site alignment with lifecycle requirements.
• Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.

 Desirable Experience:

• Education
  • Degree level qualification, science or engineering discipline or equivalent.
• Skills and Experience
  • Experienced at leading teams to deliver compliant computerised systems.
  • Good understanding of the implementation of the requirements of GAMP 5, adherence with 21CFR Pt11, EU GMP Annex 11.
  • Significant experience of validation within a parenteral (bio) pharmaceutical or blood products manufacturing environment (API and/or fill/finish).

Due to the current climate, the position, as well as all interviews, will be performed remotely for the time being.

Interested initially and keen to get the ball rolling? Apply now for immediate consideration and further information.




The candidate must have the rights to work in the location stated in the job advert.

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