Lead Validation Engineer: Process & Cleaning (Sterile)

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

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.