Staff Validation Engineer, Process and Cleaning
Thermo Fisher Scientific
Summary
The Staff Engineer, Process and Cleaning Validation supports Thermo Fisher's mission by ensuring manufacturing processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a sterile/aseptic environment.
Job description
How will you make an impact?
The Staff Engineer, Process and Cleaning Validation supports Thermo Fisher's mission by ensuring manufacturing processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a sterile/aseptic environment.
What will you do?
- Lead process validation (PPQ) and cleaning validation activities
- Develop validation strategies for new and existing products and processes
- Author and execute validation protocols and reports
- Perform data analysis to support validation conclusions
- Support change controls, deviations, and CAPAs
- Collaborate with Manufacturing, Quality, and MS&T teams
- Ensure alignment with cGMP and regulatory expectations
- Support internal and external audits and inspections
How will you get here?
Education
- Bachelor's degree in Engineering, Chemistry, Life Sciences, or related field
Experience
- 8+ years of experience in process and/or cleaning validation
- Experience in sterile/aseptic manufacturing environments (required)
- Strong knowledge of cleaning validation, including residue limits and risk-based approaches
- Experience with lifecycle validation and PPQ
Knowledge, Skills, Abilities
- Strong understanding of cGMP and regulatory requirements
- Data analysis and problem-solving skills
- Technical writing and documentation expertise
- Ability to manage multiple projects and priorities
- Strong cross-functional collaboration skills
Requirements
- Bachelor's degree in Engineering, Chemistry, Life Sciences, or related field
- 8+ years of experience in process and/or cleaning validation
- Experience in sterile/aseptic manufacturing environments
- Strong knowledge of cleaning validation, including residue limits and risk-based approaches
- Experience with lifecycle validation and PPQ
- Strong understanding of cGMP and regulatory requirements
- Data analysis and problem-solving skills
- Technical writing and documentation expertise
- Ability to manage multiple projects and priorities
- Strong cross-functional collaboration skills
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.