Senior Microbiology Specialist – QC SME

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 Youll 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 testing
• USP standards
• Growth promotion and gram staining
• Environmental monitoring in pharma settings
• Aseptic process media fills
• cGMP and Good Documentation Practices

Qualifications :

• Bachelors degree in Microbiology Biology or a closely related scientific field; Masters degree preferred
• Minimum of 4 years of hands-on microbiology experience in a GMP pharmaceutical or biologics environment
• Extensive experience with BacT rapid sterility assay endotoxin testing growth promotion and aseptic processing
• Proven expertise in mammalian cell culture techniques and aseptic manufacturing processes
• Proficiency in operating and maintaining laboratory equipment such as microscopes pH meters incubators and laminar flow hoods
• In-depth knowledge of USP standards cGMP regulations and FDA guidance documents related to microbiology in pharmaceutical manufacturing
• Strong analytical skills with the ability to interpret complex microbiological data and prepare comprehensive reports
• Excellent technical writing skills for developing SOPs change controls and qualification protocols
• Demonstrated experience in conducting investigations for out-of-specification (OOS) results and non-conformances
• Familiarity with risk assessment methodologies related to microbial contamination and product safety
• Strong problem-solving skills and the ability to implement process improvements in a microbiology laboratory setting
• Excellent communication and interpersonal skills with the ability to effectively collaborate with cross-functional teams
• Experience in training and mentoring junior laboratory staff
• Flexibility to work occasional off-shifts and weekends as required by testing schedules
• Proficiency in using laboratory information management systems (LIMS) and data analysis software
• Ability 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 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 clients quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories please explore our website .

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

Remote Work :

No

Employment Type :

Full-time