QC Microbiology Technical Specialist 

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing

If you’re looking for a rewarding career, apply with us today

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.

Core Competencies & Technical Expertise:

• Sterility and Endotoxin Testing (including BacT rapid sterility assay)
• USP <71>, <85>, <61>, <62> standards
• Growth Promotion Testing, Gram Staining, Sub-culturing
• Environmental Monitoring (viable/non-viable) in GMP cleanroom environments
• Aseptic Process Simulation (Media Fills)
• cGMP, GDP, and ALCOA++ principles
• Mammalian Cell Culture and Aseptic Processing

Primary 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.

• 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.

What to Expect in the Hiring Process: 

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

Additional Details: 

Position is Full Time, Monday – Friday First Shift with support outside of standard hours. Candidates currently living within a commutable distance of Exton, PA are encouraged to apply.

Excellent full-time benefits include:

• 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

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.