Company Description

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

Job Description

Eurofins PSS is hiring a Senior Microbiology Specialist – QC SME to support pharmaceutical quality control operations at a client site. This is a hands-on role for someone with deep expertise in microbiology who can work independently and serve as the go-to resource for microbiology-related questions and processes.

While this is not a leadership position, there is potential to grow into a leadership role over time.

What You'll Do

Perform sterility, endotoxin, pH, and osmolality testing on raw materials and drug products.Conduct gram stains, growth promotion testing, and cell culture work.Lead aseptic process media fills and related testing (e.g., visual inspection).Carry out environmental monitoring (air, surfaces, personnel, particulates) in cleanrooms.Keep lab equipment clean and maintained; ensure documentation is complete and compliant.Write and update SOPs, change controls, and qualification protocols.Investigate out-of-specification (OOS) results and non-conformances; identify root causes and implement corrective actions.Perform internal audits and walk-throughs to ensure compliance.Collaborate with Manufacturing, QA, and Facilities teams to meet production goals.Train other lab staff as needed.Develop and validate new microbiological testing methods to improve efficiency and accuracy.Participate in risk assessments related to microbial contamination and product safety.Analyze trends in microbiological data and prepare comprehensive reports for management review.Serve as a subject matter expert during regulatory inspections and customer audits.Contribute to continuous improvement initiatives by proposing and implementing process enhancements in the microbiology lab.

What You Need to Know

Sterility and endotoxin testingUSP standardsGrowth promotion and gram stainingEnvironmental monitoring in pharma settingsAseptic process media fillscGMP and Good Documentation Practices

QualificationsBachelor's degree in Microbiology, Biology, or a closely related scientific field; Master's degree preferredMinimum of 4 years of hands-on microbiology experience in a GMP pharmaceutical or biologics environmentExtensive experience with BacT rapid sterility assay, endotoxin testing, growth promotion, and aseptic processingProven expertise in mammalian cell culture techniques and aseptic manufacturing processesProficiency in operating and maintaining laboratory equipment such as microscopes, pH meters, incubators, and laminar flow hoodsIn-depth knowledge of USP standards, cGMP regulations, and FDA guidance documents related to microbiology in pharmaceutical manufacturingStrong analytical skills with the ability to interpret complex microbiological data and prepare comprehensive reportsExcellent technical writing skills for developing SOPs, change controls, and qualification protocolsDemonstrated experience in conducting investigations for out-of-specification (OOS) results and non-conformancesFamiliarity with risk assessment methodologies related to microbial contamination and product safetyStrong problem-solving skills and the ability to implement process improvements in a microbiology laboratory settingExcellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teamsExperience in training and mentoring junior laboratory staffFlexibility to work occasional off-shifts and weekends as required by testing schedulesProficiency in using laboratory information management systems (LIMS) and data analysis softwareAbility to work independently and serve as a subject matter expert during regulatory inspections and customer audits

Additional Information

What to Expect in the Hiring Process: 

10-15 Minute Phone Interview with Region Recruiter45-60 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidayYearly 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.