Staff Engineer, MSAT Validation
Thermo Fisher Scientific
Staff Engineer position supporting sterile and aseptic manufacturing validation at Thermo Fisher Scientific in Greenville, NC. The role leads validation activities across processes, cleaning, and media fill programs while maintaining compliance with cGMP and global regulatory standards.
Responsibilities
- Lead and support process validation, cleaning validation, and media fill activities for sterile manufacturing
- Develop validation strategies using lifecycle and risk-based approaches for new and existing products
- Author, review, and execute validation protocols, reports, and technical documentation
- Perform data analysis and technical assessments to support validation conclusions
- Collaborate cross-functionally with Manufacturing, Quality, and Regulatory teams on validation programs
Requirements
- Bachelor's degree in Engineering, Chemistry, Life Sciences, or related field
- 8+ years pharmaceutical and/or biotechnology validation experience
- Experience in sterile/aseptic manufacturing environments
- Strong background in process validation, cleaning validation, or media fill/aseptic process simulation
- Knowledge of cGMP, FDA, and EMA regulatory requirements
- Technical writing expertise for protocols, reports, and risk assessments
- Legally authorized to work in United States without sponsorship
Vacancy posted 6 days ago
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