Validation Engineer (contract) - Glasgow
|Job Title:||Validation Engineer (contract) - Glasgow|
|Contact Name:||Nathan Wilson|
|Job Published:||August 22, 2017 23:17|
- This company manufacture an extensive range of APIs for the pharmaceutical industry for clients throughout the UK.
- This project is part of an ongoing retrospective tech-transfer project meaning it's an exciting time to join this manufacturing site!
Working as a Validations Engineer at this API manufacturing site your main responsibilities will be:
- Full qualification and validation of on-site utilities and equipment in an API pharmaceutical manufacturing environment.
- Writing and executing documentation and protocols including URS, FMEA, DQ, IQ, OQ, and VMP.
- Ensure compliance to current GMP Engineering in relation to the MHRA Orange Guide IPSE, GAMP and CFR regulations.
- Participate in the successful completion of MHRA and FDA inspections as part of a Retrospective Qualification project.
- This role is ideal for a Validations contractor that has experience working with a wide range of manufacturing equipment and facilities and is knowledgeable of overall GMP QA requirements to allow them to liaise with the Quality Manager when required.
- Bachelor's degree in science, pharmacy, biological science or engineering field is preferred.
- Hands-on international validation experience in pharmaceutical/ biotech industry.
- Wide range of qualification experience across different equipment and utility types.
- Experience and the ability to carry out full IQ, DQ, CQ, OQ, and PQ protocols
- Packaging and cold chain validation experience is preferred.
- Excellent verbal and written communication skills, ability to work well in teams or independently and the ability to prioritise work and manage multiple projects while maintaining quality and compliance.
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