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Validation Engineer

4 months ago

Hertford, United Kingdom PM Group Remote Work Freelance Full time

A clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies based in the South West of the UK are seeking an Equipment Validation Consultant.

Responsibilities:

  • Process equipment qualification and related activities to support new manufacturing equipment project
  • Equipment, isolators, prodigy, CRF's, SEPEX, LIPPKE, fridges, freezers
  • To adhere to systems and procedures required to complete the project
  • Write, review, execute CQV lifecycle documents (e.g IOPQ protocols and reports) for process equipment, as defined in the validation plan for the project
  • Work within the multifunctional project team, interacting and forming effective relationships with the key function representatives (e.g. Production, QA, Engineering)
  • Contractor will mostly need to be on site to interact with stakeholders as required by the project as the role involves a strong bias to protocol execution.

Qualifications:

  • Applicants will have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors, along with bench scale/small scale, lab, R&D or quality experience. within a validation role.
  • Successful candidates will be able to demonstrate technical competence, will be able to work efficiently and safely, and will be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable.

Outside of IR35

5 x days onsite

July start