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Validation Engineer

2 months ago

Cambridgeshire, United Kingdom PM Group Full time

PM Group is seeking a Validation Engineer to join a client in the Cambridgeshire region.


Scope of work:

  • Review DIRA (data integrity risk assessments) of equipment to identify data integrity risk-level and data control shortfalls (pre-upgrade).
  • Review VDS (validation determination statement) documents to familiarise with the validation deliverables for each equipment control system being upgraded.
  • Execute systems upgrade work as required (URS, DQ, validation planning, validation protocol review/writing, execution of CSV, writing FVR (final validation report), writing RTM (requirements traceability matrix).
  • Assist with procedure writing and retraining of system users.
  • Provide project planning services as required to assist the OT & automation manager with the upgrade project.


Requirements:

  • Applicants will have experience of equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors.
  • 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.

Onsite

6 months

Outside IR35