JOB INFORMATION

Date Opened
06/02/2025
Job Type
Full time
Work Experience
3-5 years
Industry
Pharma
City
York
State/Province
Pennsylvania
Country
United States

JOB DESCRIPTION

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

THE EXPERIENCE

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

REQUIREMENTS

• Bachelor’s Degree in related scientific discipline, Microbiology preferred.
• 3-5+ years of experience in QC Microbiology function within the pharmaceutical industry.
• Prior experience in aseptic manufacturing environment is preferred.
• Understanding of aseptic technique, processes, and compliance.
• Understanding of industry regulations and compliance.
• Experience with disinfectant efficacy studies and facility validation is highly preferred.
• Experiene working in biosafety cabinets.
• Excellent communication skills, both verbal and written.
• Strong attention to detail and organizational skills.
• Excellent analytical and problem-solving skills.Ability to work both independently and collaboratively in a team setting.

We are hiring an experienced Microbiologist for 2nd shift, supporting 3pm-11pm in York, PA. This role will support microbiological testing and environmental monitoring activities to ensure compliance with cGMP and regulatory standards.

• Perform routine microbiological testing including endotoxin, bioburden, microbial identification, microbial limits testing, sterility testing, media growth promotion, environmental monitoring, and critical utilities collection and testing.
• Conduct environmental monitoring including viable air and surface sampling, non-viable particle monitoring, etc.
• Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring.
• Perform and document investigations for environmental monitoring excursions and incidents during aseptic filling routine monitoring.
• Perform required risk assessments and participate in investigations of microbiological deviations and out-of-specification (OOS) results.
• Write, review, and approve standard operating procedures and coordinate/execute method development and method validation.
• Document all activities in accordance with Good Documentation Practices.
• Support the QC Microbiology group in internal audits, external client audits, and global regulatory audits as needed.
• Coordinate and assist in the validation, calibration, and maintenance of laboratory instrumentation and equipment.
• Maintain laboratory supplies, equipment calibration, and cleanliness.
• Adhere to all safety and compliance protocols.
• Additional responsibilities as assigned.