Validation Specialist
4 days ago
PM Group is seeking a skilled professional to join our team as a Validation Engineer.
- Review and analyze DIRA (data integrity risk assessments) to identify data integrity risk-level and data control shortfalls.
- Review VDS (validation determination statement) documents to familiarize with the validation deliverables for each equipment control system being upgraded.
- Execute systems upgrade work as required, including URS, DQ, validation planning, validation protocol review/writing, execution of CSV, writing FVR (final validation report), and 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.
- 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, work efficiently and safely, and be willing to supervise and train others in any specialist areas of which the candidate is knowledgeable.
Work Arrangement:
Onsite
6 months
Outside IR35
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