Validation Engineer

• 5-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment • Hands on experience operating/validating various laboratory instrument systems (e.g. AA, FT-IR, IC, ICP-MS, TOC, UV_Vis). • Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system’s data integrity and FDA 21 CFR Part 11 controls. • 3-5 years of experience in performing periodic review of laboratory instruments including those with computerized systems. • Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements. • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices • Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes. • Ability to manage multiple activities and constantly change priorities. • Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments with various areas (Chemistry, Micro, Biological, EM etc.) • Strong critical thinking and problem solving skills.
Reference : Validation Engineer jobs

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