Engineer III, Validation - Process & Cleaning [Remote]

JOB DESCRIPTION

Work Schedule

Environmental Conditions

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