Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Key responsibilities:
- Generate and implement validation life cycle documentation such as site acceptance test (SAT), system risk assessment (SRA), design qualification (DQ), installation and operation qualification (IOQ), qualification summary report (QSR) and deviation report for process and utilities equipment as per Thermofisher standard operation procedure (SOP).
- Implement approved protocols, identify non-conformances to User Requirements
- Write Requirements Traceability Matrix (RTM) for comments and acquire approval.
- Review and comment pre-execution vendor commissioning protocols. Witness protocol execution. Ensure testing is complete and record test results in accordance with GDP.
- Write PQ protocols, issue for comments, and acquire pre-execution approval.
- Support compute system validation activities.
- Work closely with a multi-functional team not limiting to manufacturing and quality assurance.
Education:
- An engineering degree with no less than 5 years working as a CQV engineer in a pharmaceutical industry.
Experience:
- Extensive knowledge of validation activities including plan and protocol generation, execution, final report approval/closeout and change control.
- Proficient with computers (MS office). Shown understanding of controlled documentation and data systems.
At Thermo Fisher Scientific, each one of our 75,000 outstanding minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
