Senior MSAT Validation Engineer - Sterile & Aseptic

Regulatory Jobs; Greenville (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental, & Vision benefits

Paid Time Off & Holidays

401K Company Match

Tuition Reimbursement

Employee Referral Bonus

Employee Discount Program

Recognition Program

Parental Leave

PPE provided

Job summary

Thermo Fisher Scientific Inc. in Greenville, NC is seeking a Staff Engineer, MSAT Validation to lead validation activities across sterile processes, cleaning, and media fill. You will develop risk-based validation strategies and ensure compliant manufacturing operations.

You will collaborate with Manufacturing, Quality, MSAT/Manufacturing Science, and Regulatory teams to maintain validated state and support audits, cGMP compliance, and continuous improvement in contamination control strategies.

Qualifications

• Bachelor's degree required in engineering/chemistry/life sciences or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Experience in sterile/aseptic manufacturing environments.
• Experience with validation lifecycle activities and risk-based approaches.

Responsibilities

• Lead and/or support process validation (PPQ), cleaning validation, and media fill activities for sterile/aseptic manufacturing.
• Develop validation strategies using lifecycle and risk-based approaches.
• Author, review, and execute validation protocols, reports, risk assessments, and related documentation.
• Perform data analysis to support validation conclusions and ongoing maintenance.
• Support investigations, deviations, change controls, and CAPAs related to validation.
• Collaborate with Manufacturing, Quality, MSAT/Manufacturing Science, and Regulatory teams to deliver validation programs.
• Ensure validation activities align with cGMP and regulatory expectations (FDA/EMA).

Skills

Aseptic processing

Contamination control

Validated-state principles

cGMP knowledge

Regulatory requirements

Technical writing

Data analysis

Project leadership

Cross-functional collaboration

Audits & CAPAs

Education

Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related field

Job description

Thermo Fisher Scientific Inc. in Greenville, NC is seeking a Staff Engineer, MSAT Validation to lead validation activities across sterile processes, cleaning, and media fill. You will develop risk-based validation strategies and ensure compliant manufacturing operations.

You will collaborate with Manufacturing, Quality, MSAT/Manufacturing Science, and Regulatory teams to maintain validated state and support audits, cGMP compliance, and continuous improvement in contamination control strategies.