Performance Validation Specialist
4 days ago
This is an exciting opportunity to join Thermo Fisher Scientific as a Performance Validation Engineer, where you will be responsible for providing specialized validation knowledge and expertise to support operations and clients. The successful candidate will complete all protocols related to the validation of equipment, processes, and new products, ensuring that documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements, and Good Manufacturing Practices.
Key Responsibilities- Protocol Development: Prepare validation protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for complex equipment, facilities, and computer systems.
- Protocol Execution: Execute protocol, report deviations, and participate in deviation analysis and resolution.
- Data Review: Participate in the data specifications and format review process.
- Inventory Management: Maintain site computerized system inventory list.
- Compliance Assessment: Conduct 21 CFR Part 11 assessment and Data Integrity assessment for computerized systems.
- Safety and Documentation: Maintain a safe working environment, report potential hazards, and maintain documentation archiving.
To succeed in this role, you should have a high school diploma/General Educational Development (GED) Certificate and be currently enrolled in a Coop B.Sc. Program in Computer Science, Mechanical Engineering, Chemical Engineering, Life Science, or related fields. Previous experience in a validation or science-related environment is also required.
What We OfferWe offer a competitive salary range of $65,000 - $85,000 per annum, depending on qualifications and experience. You will also enjoy a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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Performance Validation Specialist
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Whitby, North Yorkshire, United Kingdom Thermo Fisher Scientific Full timeJob Summary:As a Performance Validation Specialist at Thermo Fisher Scientific, you will play a key role in supporting operations and clients with specialized validation knowledge and information. This position requires a strong understanding of Good Manufacturing Practices (GMP) and the ability to ensure documents conform to Patheon Standard Operating...
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Validation Engineering Expert
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