Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Engineer 3 - Validation, Process & Cleaning

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeGreenville, NC, USANo salary listed

About the Job

Requirements

A bachelor's degree and at least 4 years of validation experience are required.
Experience in pharmaceutical or biotech manufacturing is required.
Strong experience with process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ) is required.
Ability to write and execute validation protocols and reports is required.
Experience with validation documentation and regulatory standards is required.
Exposure to audits, audit responses, or regulatory inspections is required.
Problem-solving and deviation investigation skills are required.
Onsite availability in Greenville, North Carolina, Monday through Friday, with flexibility as needed, is required.
Cleanroom and production-floor exposure is required.

Responsibilities

Lead validation activities, including process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ).
Support tech transfers and new product introductions.
Collaborate with Operations, QC, and Quality teams.
Participate in client interactions, audits, and regulatory readiness.
Own complex validation projects and act in a project management capacity as needed.
Contribute to audits, deviation investigations, and continuous improvement.
Write protocols, analyze data, investigate deviations, and prepare reports; approximately 70% of the role is desk-based.
Execute validation in sterile manufacturing environments; approximately 30% of the role is on the production floor.

Desired Qualifications

Direct experience in sterile or aseptic pharmaceutical manufacturing, including aseptic filling, sterile processing, or cleanroom environments, is highly preferred.
Experience in both process and cleaning validation is preferred.
A background in sterile filling or manufacturing operations is preferred.
Knowledge of FDA, EMA, and cGMP regulations is preferred.

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

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size: 10,001+
Company stage: IPO
Headquarters: Waltham, MA
Founded: 1956

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