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ThermoFisher Scientific

Engineer III, Validation - Process & Cleaning

Greenville, NC, United States

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Job details

Experience: Bachelor’s degree and 4+ years validation experience
Posting language: English
Posted: Sep 13, 2026

Original 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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More about this job

Skills

Cleaning
Good manufacturing practices
Microsoft Office
Pharmaceutical processes
Regulatory compliance
Data analysis
Reporting
SAP IQ
Leadership
Project management
Process improvement
Documentation
Inspection
Problem solving

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