Staff Validation Engineer, Process and Cleaning
Full-time
Thermo Fisher Scientific
Staff Validation Engineer supporting process and cleaning validation activities for sterile manufacturing at Thermo Fisher Scientific. Ensures manufacturing processes and cleaning procedures meet regulatory compliance and quality standards in aseptic environments.
Responsibilities
- Lead process validation and cleaning validation activities for manufacturing
- Develop validation strategies for new and existing products and processes
- Author and execute validation protocols and generate reports
- Support change controls, deviations, and corrective action requests
- Collaborate with Manufacturing, Quality, and Materials Science teams
Requirements
- Bachelor's degree in Engineering, Chemistry, Life Sciences, or related field
- 8+ years process and/or cleaning validation experience
- Sterile/aseptic manufacturing environment experience required
- Knowledge of cleaning validation, residue limits, and risk-based approaches
- Strong cGMP and regulatory requirements understanding
- Data analysis, problem-solving, and technical writing expertise
Vacancy posted 1 day ago
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