Engineer III, Validation - Process & Cleaning
- Company: Thermo Fisher Scientific
- Location: Greenville, North Carolina, United States of America
- Work mode: On-site
- Job type: Full-Time
- Posted: 2026-09-29
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