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Validation Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom PM Group Full time
Validation Engineer Opportunity

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

Key Responsibilities:

  • Review DIRA (data integrity risk assessments) to identify data integrity risk-level and data control shortfalls.
  • Review VDS (validation determination statement) documents to familiarize with validation deliverables.
  • Execute systems upgrade work, including URS, DQ, validation planning, protocol review/writing, CSV execution, and FVR writing.
  • Assist with procedure writing and retraining of system users.
  • Provide project planning services to assist the OT & automation manager.

Requirements:

  • Experience in equipment validation on multiple projects in the pharmaceutical and/or biopharmaceutical sectors.
  • Technical competence, ability to work efficiently and safely, and willingness to supervise and train others.

Working Arrangements:

Onsite, 6 months, Outside IR35.