Engineer III, Validation - Process & Cleaning

Engineer III, Validation - Process & Cleaning Thermo Fisher Scientific - 3.4 Greenville, NC Job Details Full-time 1 day ago Qualifications Regulatory inspections Pharmaceutical regulatory compliance Safety standards in production Data analysis skills Compliance audits & assessments GMP Mid-level Bachelor's degree Continuous improvement Scientific protocols Pharmaceutical plant experience Technical writing Quality standards in production Cleanroom Quality audits Manufacturing 4 years Cross-functional collaboration Project leadership Regulatory compliance management Cross-functional communication FDA regulations Engineering validation Full Job Description 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