Job Description
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, 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?
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. The Staff Engineer, Media Fill plays a critical role in supporting sterile/aseptic manufacturing operations by leading media fill (aseptic process simulation) programs. This role ensures processes remain in a validated state and compliant with global regulatory expectations.
What will you do?
- Lead the design and execution of media fill (APS) studies for aseptic manufacturing processes
- Author and review validation protocols, reports, and risk assessments
- Support investigations, deviations, and CAPAs related to media fills and aseptic processes
- Partner cross-functionally with Manufacturing, Quality, and Regulatory teams
- Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements
- Drive continuous improvement initiatives in validation and contamination control strategies
How will you get here?
Education:
- Bachelor’s degree in Engineering, Life Sciences, or related field
Experience:
- 8+ years of experience in pharmaceutical/biotech validation
- Strong experience with aseptic processing and media fill execution (required)
- Experience in sterile manufacturing environments (required)
Knowledge, Skills, Abilities:
- Deep understanding of aseptic processing and contamination control
- Strong knowledge of cGMP and regulatory expectations
- Technical writing expertise (validation protocols and reports)
- Ability to lead complex validation projects independently
- Strong collaboration and communication skills
Numbers & Facts
| Location | Greenville, North Carolina |
| Industry | All |
| Company Size | 10,000 employees or more |
| Website | https://corporate.thermofisher.com/en/home.html |
About Company
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.
Skills
- Asepsisunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Cleanroomunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Manufacturing/Industrial Processesunmatched
- Process Improvementunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Risk Analysisunmatched
- Safety Standardsunmatched
- Simulationunmatched
- Team Playerunmatched
- Technical Writingunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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