About the role
Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
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