QC Microbiology Technical Specialist 

Eurofins • Exton, PA

113d

About The Position

Eurofins PSS is seeking a QC Microbiology Technical Specialist to serve as the primary technical resource for microbiological quality control activities within a GMP-regulated pharmaceutical environment. This role is embedded at a client site and requires a highly experienced professional capable of independently executing complex microbiological assays, supporting compliance initiatives, and serving as the go-to expert for microbiology-related inquiries. While not a formal leadership role, this position offers potential for future advancement into leadership based on performance and business needs.

Requirements

• Bachelor's degree in Microbiology, Biology, or a related scientific discipline.
• Minimum of 4 years of microbiology experience in a GMP-regulated pharmaceutical or biologics environment.
• Demonstrated expertise in sterility testing, endotoxin analysis, aseptic processing, and environmental monitoring.
• Experience with cell therapy manufacturing is preferred.
• Proficient in the use of standard laboratory instrumentation (microscopes, pH meters, incubators).
• Strong written and verbal communication skills; ability to convey technical information clearly.
• Willingness to work occasional off-shift and weekend hours as required.
• Ability to work independently and train others in a dynamic, fast-paced environment.

Nice To Haves

• Experience with cell therapy manufacturing.

Responsibilities

• Perform sterility, endotoxin, pH, and osmolality testing on raw materials, intermediates, and finished drug products.
• Conduct microbiological assays including gram staining, growth promotion, isolate sub-culturing, and cell culture maintenance.
• Coordinate and execute testing schedules aligned with manufacturing operations.
• Lead execution and support of aseptic process simulations (media fills), including associated visual inspections.
• Maintain laboratory compliance through equipment calibration, housekeeping, and accurate documentation.
• Author and revise SOPs, change controls, and qualification protocols for microbiological methods.
• Investigate Out-of-Specification (OOS) results and author comprehensive investigation reports; implement CAPAs as needed.
• Ensure data integrity and compliance with ALCOA++ and GDP standards across all documentation and systems.
• Conduct internal audits and GEMBA walk-throughs to ensure regulatory compliance.
• Collaborate with cross-functional departments (Manufacturing, QA, Facilities) to support operational goals.
• Perform environmental monitoring (air, surface, personnel, particulate) within aseptic manufacturing areas.
• Provide oversight during critical aseptic manufacturing steps to ensure procedural accuracy.
• Train and mentor junior staff and support onboarding of new laboratory personnel.

Benefits

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holiday.
• Yearly goal-based bonus & eligibility for merit-based increases.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree