Staff Validation Engineer, Process and Cleaning

Work Schedule

• Environmental Conditions
• 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