Staff Validation Engineer, Process and Cleaning
Job Location:
Greenville, NC - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 Fishers 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:
- Bachelors 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
Required Experience:
Staff IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
