Engineer III, Validation - Process & Cleaning

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