Job Description
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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
