Engineer 3 Validation - Process & Cleaning

**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