Technical Fellow – Medical Device Microbiology

The Technical Fellow – Medical Device Microbiology is the senior technical leader for microbiology. This role sets technical direction, standards, and decisions to ensure consistent, high-quality, and compliant services. They drive standardization, build technical expertise, and support business growth. This position is intended to lead technical direction across the organization, influence standards and capabilities enterprise-wide, and guide senior technical staff (not responsible for daily lab operations).

Some major focus areas of the Technical Fellow are as follows:

1. Standardization & Quality

• Ensure consistent testing methods, data interpretation, and reporting
• Reduce variability across teams
• Support troubleshooting and continuous improvement

2. Regulatory & Strategy

• Translate FDA, ISO, and USP requirements into clear actions
• Anticipate industry changes and adapt technical strategies
• Support growth areas like sterilization, cleaning, and disinfection

3. Talent & Expertise

• Build and develop SME capabilities
• Define skill expectations and training priorities
• Reduce reliance on single experts

4. Governance

• Serve as the escalation point for complex technical issues
• Provide clear, binding technical decisions

Required

• Advanced degree in Microbiology, Biology, or related field (preferred)
• 12–15+ years of experience in medical device microbiology
• Deep expertise in:
  • Sterility, bioburden, and endotoxin testing
  • Sterilization processes (Steam & EO preferred)
  • Reprocessing, cleaning, and disinfection validation
• Strong working knowledge of FDA, ISO, and USP frameworks
• Demonstrated experience as a technical authority influencing senior technical professionals

Preferred

• Experience in contract testing or services environment
• Experience defining technical standards across multiple teams or sites
• Experience supporting regulatory submissions and audits

The position is full-time, Monday-Friday, 8:00am-5:00pm, with overtime as needed. Candidates living within a commutable range of Lancaster, PA are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.