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