Validation Engineer

• 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.