Engineer III, Validation - Process & Cleaning — Greenville, North Carolina, USA

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