Validation Engineer

3 weeks ago

Suffolk, United Kingdom PM Group Full time

PM Group is seeking a Validation Engineer to join an API Manufacturing facility in Suffolk for 3-4 months.

Responsibilities

* Work closing with Capital Project, Production, QA, and R&D departments to get the validation scopes and agreements to release the desired production status in the agreed timelines.

* Weekly update to report the progress status of the validation works.

* Perform General Validation works for the impacted GMP and non-GMP systems as part of the CP-0361 Bond-Bio project.

* Update and draft the required validation documentation, including but not limited to CSV/CQV validation protocols, VP, C&QP, SIA, URS, DRR/VRA, IOQ, OCD, C&QR, RTM, and VR.

* Execution and approval of the corresponding protocols to release the required equipment for GMP production

* Weekly Validation Report

* Draft, execution, and approval CSV/CQV validation protocols

Qualifications & Requirements

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

* Working with other departments and key stakeholders

* Good communication skills and be proactive

* 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

Outside IR35

3-4 months project

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