Engineer III, Validation - Process & Cleaning

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