Validation Engineer III
4 days ago
Job Summary
Thermo Fisher Scientific is seeking a highly skilled Validation Engineer III to join our team. As a key member of our validation team, you will be responsible for ensuring the accuracy and reliability of our computer systems, equipment, and processes.
Key Responsibilities
- Prepare and execute validation documentation, including VP, IQ, OQ, and PQ reports
- Support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, and Process Failure Modes and Effects Analysis
- Perform risk assessment and mitigation to ensure compliance with regulatory requirements
- Conduct validation tests and analyze data to determine whether systems or processes have met validation acceptance criteria
- Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) activities and protocols
Requirements
- Four-year Bachelor of Science degree in an Engineering or Science discipline
- 2+ years of validation experience in a regulated industry or equivalent experience
- Knowledge of Controlled Temperature Unit Operation and Management
- PC literacy, including the ability to generate complex documents in Microsoft Excel and Microsoft Word
What We Offer
Thermo Fisher Scientific offers a competitive salary, annual incentive bonus plan, 401K with company match, tuition reimbursement, and a range of other employee benefits. We foster an exciting company culture that encourages innovation, forward-thinking, and outstanding career and development prospects.
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