Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Discover Impactful Work:
Join Thermo Fisher Scientific and be part of a team delivering life-changing therapies through world-class sterile pharmaceutical manufacturing.
As a Validation Engineer III, you will lead validation activities supporting process and cleaning validation in sterile environments, playing a key role in ensuring compliance, quality, and successful product launches.
This role offers high visibility and cross-functional exposure, working across Operations, Quality, and QC Labs—often acting as a technical lead during tech transfers and validation execution.
A Day in the Life:
•~70% desk-based: protocol writing, data analysis, deviation investigations, reporting
•~30% on the floor: executing validation in sterile manufacturing environments
•Lead validation activities including:
•Process validation
•Cleaning validation
•Equipment qualification (IQ/OQ/PQ)
•Support tech transfers and new product introductions
•Collaborate cross-functionally with Ops, QC, and Quality teams
•Participate in client interactions, audits, and regulatory readiness
What to Expect:
•Ownership of complex validation projects
•High exposure across site operations and leadership teams
•Opportunity to act in a project management capacity
•Involvement in audits, deviations, and continuous improvement
Keys to Success:
Education & Experience:
•Bachelor’s degree and 4 years validation experience
•Experience in pharmaceutical or biotech manufacturing required
•Direct experience in sterile/aseptic pharmaceutical manufacturing highly preferred:
•Aseptic filling
•Sterile processing
•Cleanroom environments
Skills & Expertise:
•Strong experience with:
•Process validation
•Cleaning validation
•Equipment qualification (IQ/OQ/PQ)
•Proven ability to write and execute validation protocols and reports
•Experience with validation documentation and regulatory standards
•Exposure to audits, audit responses, or regulatory inspections
•Strong problem-solving and deviation investigation skills
Preferred:
•Experience in both process and cleaning validation
•Background in sterile filling or manufacturing operations
•Knowledge of FDA, EMA, and cGMP regulations
Work Environment & Requirements:
•Onsite role in Greenville, NC
•Monday–Friday schedule with flexibility as needed
•Cleanroom and production floor exposure required
Why Join Us:
•Work on cutting-edge sterile pharmaceutical programs
•Gain broad cross-functional exposure across the site
•Be part of high-impact tech transfers and product launches
•Clear path to senior and leadership roles