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Job Role: Validation Engineer
Contract: W2
Location: Newark CA
Position Overview/Responsibilities:
- Ensure quality and compliance with established procedures and standards.
- Generate review and approve baselevel documents such as the Validation Plan URS FRS DS and SOPs.
- Generate review/approve and execute computer validation (IQ OQ and PQ) documentation for GxP systems from Quality Control Units.
- Develop implement and maintain computer system validationrelated controlled documents to support the initiation validation operation and maintenance of GxP systems.
- Assist with change controls CAPAs deviations and exceptions required as part of system validation efforts.
- Support system administrative & maintenance activities for Lab Systems.
Required Skills:
- 6 years experience in the pharmaceutical industry with GMP experience.
- Experience with validation of cGMP automation within FDAregulated environments.
- Understanding phases of the Life Cycle Validation approach.
- Knowledge of GAMP 5 21 CFR Part 11 and Part 211 EudraLex Volume 4 and Annex 11 and ICH Q7 Q8 Q9 and Q10.
- Ability to manage multiple projects.
- Bachelors Degree in Engineering Science or a related technological field.