Engineer III, Validation - Process & Cleaning

ThermoFisher Scientific; Greenville (NC); On-site; USD 95,000 - 125,000; Full time

Job summary

Thermo Fisher Scientific in Greenville, NC is seeking a Validation Engineer III to lead validation activities across process, cleaning, and IQ/OQ/PQ in sterile environments. You will write protocols, analyze data, investigate deviations, and drive successful tech transfers and new product introductions.

This role offers high visibility within Operations, Quality, and QC labs, with opportunities to influence audits and regulatory readiness while advancing toward senior technical leadership.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 4+ years of validation experience in pharmaceutical or biotech manufacturing.
• Direct experience in sterile/aseptic pharmaceutical manufacturing is highly preferred.
• Aseptic filling, sterile processing, and cleanroom environments experience.

Responsibilities

• Lead validation activities including process validation, cleaning validation, and IQ/OQ/PQ.
• Write and execute validation protocols and reports.
• Support tech transfers and regulatory readiness.
• Collaborate across Ops, QC, and Quality teams.
• Participate in audits and regulatory inspections.

Skills

Process validation

Cleaning validation

IQ/OQ/PQ

Validation documentation

Regulatory audits

Deviation investigations

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

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.