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ThermoFisher Scientific

Staff Validation Engineer, Process and Cleaning

Greenville, NC, United States

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Job details

Experience: 8+ years of experience in process and/or cleaning validation
Posting language: English
Posted: Sep 13, 2026

Original 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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More about this job

Skills

Cleaning
Good manufacturing practices
Microsoft Office
Personal protective equipment
Manufacturing processes
Perform data analysis
Inspection
Data analysis
Problem solving
Technical writing
Documentation
Collaboration

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