Staff Engineer, MSAT Validation

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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific Information

Greenville, NC

How will you make an impact?

The Staff Engineer, MSAT Validation supports sterile and aseptic manufacturing by leading validation activities across processes, cleaning, and media fill (aseptic process simulation) programs. This role helps maintain validated state, support compliant manufacturing operations, and drive effective, science- and risk-based validation strategies.

This position may support one or more validation disciplines based on business needs, including process validation, cleaning validation, and media fill/aseptic process simulation. The role is expected to provide technical leadership on complex validation work while collaborating across functions in a sterile manufacturing environment.

What will you do?

• Lead and/or support process validation (PPQ), cleaning validation, and media fill (aseptic process simulation) activities for sterile/aseptic manufacturing processes.


• Develop validation strategies for new and existing products, processes, and cleaning procedures using lifecycle and risk-based approaches.


• Author, review, and execute validation protocols, reports, risk assessments, and related technical documentation.


• Perform data analysis and technical assessment to support validation conclusions and ongoing maintenance of the validated state.


• Support investigations, deviations, change controls, and CAPAs associated with validation and aseptic manufacturing activities.


• Partner cross-functionally with Manufacturing, Quality, MS&T/Manufacturing Science, and Regulatory teams to deliver validation programs.


• Ensure validation activities align with cGMP and applicable global regulatory expectations, including FDA and EMA requirements.


• Support internal and external audits and inspections and contribute to continuous improvement of validation and contamination control strategies.

How will you get here?

*Must be Legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check to include drug screening.

Education

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

Experience

• 8+ years of experience in pharmaceutical and/or biotechnology validation.


• Experience in sterile/aseptic manufacturing environments (required).


• Strong experience in one or more of the following: process validation/PPQ, cleaning validation, or media fill/aseptic process simulation.


• Experience with validation lifecycle activities and risk-based approaches.

Knowledge, Skills, Abilities

• Strong understanding of aseptic processing, contamination control, and validated-state principles.


• Strong knowledge of cGMP and applicable regulatory requirements and expectations.


• Technical writing and documentation expertise, including validation protocols and reports.


• Data analysis, technical assessment, and problem-solving skills.


• Ability to lead complex validation projects independently and manage multiple priorities.


• Strong cross-functional collaboration, communication, and stakeholder management skills.


• Ability to support audits, inspections, investigations, deviations, change controls, and CAPAs.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not a comprehensive list of all the duties and responsibilities associated with it.

Competitive wages & Excellent benefits package

• Review our company’sTotal Rewards


• Medical, Dental, & Vision benefits-effective Day 1


• Paid Time Off & Holidays


• 401K Company Match up to 6%(after 1 year)


• Tuition Reimbursement – eligible after 90 days


• Employee Referral Bonus


• Employee Discount Program


• Recognition Program


• Charitable Gift Matching


• Company Paid Parental Leave


• We will provide the vital equipment for your role including: computer, monitor, keyboard, mouse, etc.


• We also provide any Personal Protective Equipment you may need including: lab coats, safety glasses, safety shoes, etc.

For more information on our benefits, please visit:https://jobs.thermofisher.com/global/en/total-rewards