Engineer III, Validation - Process & Cleaning

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.

~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

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

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

Strong experience with:

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

Experience in both process and cleaning validation

Background in sterile filling or manufacturing operations

Knowledge of FDA, EMA, and cGMP regulations

Onsite role in Greenville, NC

Monday–Friday schedule with flexibility as needed

Cleanroom and production floor exposure required

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