Engineer III, Validation - Process & Cleaning

Work Schedule

Standard (Mon-Fri)

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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:

• 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

• 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

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.