Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
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.
- ~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
- 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
- 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
- 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
- Experience in both process and cleaning validation
- Background in sterile filling or manufacturing operations
- Knowledge of FDA, EMA, and cGMP regulations
- Onsite role in Greenville, NC
- Monday–Friday schedule with flexibility as needed
- Cleanroom and production floor exposure required
- 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