Engineer III, Validation - Process & Cleaning
About The Position
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
Requirements
- 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
- 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
Nice To Haves
- Experience in both process and cleaning validation
- Background in sterile filling or manufacturing operations
- Knowledge of FDA, EMA, and cGMP regulations
Responsibilities
- 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
- Protocol writing, data analysis, deviation investigations, reporting
- Executing validation in sterile manufacturing environments
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
