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Staff Validation Engineer, Process and Cleaning

Thermo Fisher

Greenville, NC

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JOB DETAILS
SKILLS
Asepsis, Biology, Change Control, Chemistry, Cleanroom, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, External Audit, GMP (Good Manufacturing Practices), Internal Audit, Manufacturing, Manufacturing/Industrial Processes, Multitasking, Process Validation, Project/Program Management, Regulations, Regulatory Requirements, Risk, Safety Standards, Strategic Planning, Team Player, Technical Writing, Validation Plan, Writing Skills
LOCATION
Greenville, NC
POSTED
Today
Staff Engineer, Process And Cleaning Validation

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How Will You Make An Impact?

The Staff Engineer, Process And Cleaning Validation supports Thermo Fisher's mission by ensuring manufacturing processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a sterile/aseptic environment.

What Will You Do?

  • Lead process validation (PPQ) and cleaning validation activities
  • Develop validation strategies for new and existing products and processes
  • Author and execute validation protocols and reports
  • Perform data analysis to support validation conclusions
  • Support change controls, deviations, and CAPAs
  • Collaborate with Manufacturing, Quality, and MS&T teams
  • Ensure alignment with cGMP and regulatory expectations
  • Support internal and external audits and inspections

How Will You Get Here?

Education:

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

Experience:

  • 8+ years of experience in process and/or cleaning validation
  • Experience in sterile/aseptic manufacturing environments (required)
  • Strong knowledge of cleaning validation, including residue limits and risk-based approaches
  • Experience with lifecycle validation and PPQ

Knowledge, Skills, Abilities:

  • Strong understanding of cGMP and regulatory requirements
  • Data analysis and problem-solving skills
  • Technical writing and documentation expertise
  • Ability to manage multiple projects and priorities
  • Strong cross-functional collaboration skills

About the Company

T

Thermo Fisher

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html

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