Thermo Fisher Scientific
Thermo Fisher Scientific

Engineer III, Validation - Process & Cleaning

Greenville, NC, US • Posted 1 day ago • Updated 4 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • GMP
  • Regulatory Compliance
  • IT Management
  • Writing
  • Data Analysis
  • Reporting
  • Collaboration
  • Quality Control
  • Expect
  • Project Management
  • Continuous Improvement
  • Management
  • Manufacturing
  • IQ
  • OQ
  • PQ
  • Documentation
  • Auditing
  • Conflict Resolution
  • Problem Solving
  • Manufacturing Operations
  • Good Manufacturing Practice
  • Pharmaceutics
  • Leadership

Summary

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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10286239
  • Position Id: a50abd62a76cf21f279a268633e6c532
  • Posted 1 day ago
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