Role at a glance
- Salary
- Not Disclosed
- Location
- Greenville, North Carolina, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 4+ years validation experience
- Education
- Bachelor’s degree and 4+ years validation experience
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Role Summary
Engineer III role leading process and cleaning validation activities in sterile pharmaceutical manufacturing at an onsite Greenville, NC location. The role is about 70% desk-based (protocol writing, data analysis, deviation investigations, reporting) and about 30% on the production floor executing validation.
What You'll Do
- Lead process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ)
- Support tech transfers and new product introductions
- Collaborate cross-functionally with Operations, QC, and Quality teams
- Write validation protocols and reports, analyze data, and investigate deviations
- Participate in client interactions, audits, and regulatory readiness
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor’s degree with 4+ years of validation experience in pharmaceutical or biotech manufacturing, with strong process, cleaning, and equipment qualification skills.
Required
- Bachelor’s degree
- 4+ years validation experience
- Experience in pharmaceutical or biotech manufacturing
- Strong experience with process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ)
- 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
- Direct experience in sterile/aseptic pharmaceutical manufacturing (aseptic filling, sterile processing, cleanroom environments)
- Experience in both process and cleaning validation
- Background in sterile filling or manufacturing operations
- Knowledge of FDA, EMA, and cGMP regulations
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob 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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.