Microbiologist II
About The Position
Penn Life Sciences is seeking a Microbiologist II to join our team in Langhorne, PA. The Microbiologist II will perform and oversee microbiological testing and aseptic monitoring in support of sterile and oral solid dosage manufacturing. This role ensures compliance with cGMP and regulatory requirements while supporting sterility assurance, contamination control, and environmental monitoring programs. The ideal candidate will demonstrate strong technical expertise in microbiology, a working understanding of aseptic techniques, and experience supporting investigations and laboratory data review within a regulated environment.
Requirements
- Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life-science discipline required; Master's degree preferred.
- Minimum 3-6 years of relevant microbiological or quality control laboratory experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
- Demonstrated proficiency in aseptic techniques, environmental monitoring, and microbiological testing of sterile products.
- Comprehensive understanding of microbiological principles, contamination control, and sterility assurance practices.
- Familiarity with microbial identification methods and laboratory information systems (e.g., LIMS, MODA).
- Strong analytical, organizational, and documentation review skills with a focus on accuracy and compliance.
- Effective written and verbal communication skills and ability to collaborate across Quality, Production, and Facilities functions.
Responsibilities
- Perform microbiological testing on raw materials, in-process, finished product, and stability samples, including bioburden, endotoxin, and sterility testing.
- Conduct environmental and personnel monitoring within aseptic and cleanroom areas to support contamination control programs.
- Execute and document validation and qualification studies for sterilization, depyrogenation, and aseptic process simulations.
- Support laboratory investigations, deviations, and data review to ensure compliance and data integrity under ALCOA principles.
- Draft and revise SOPs, protocols, and forms to enhance laboratory procedures and ensure regulatory readiness.
- Maintain laboratory safety, equipment calibration, and inventory control in accordance with site policies and cGMP standards.
Benefits
- 401(k) with company match
- Health, vision, and dental Insurance
- Childcare expense reimbursement
- Tuition reimbursement
- Annual bonus eligibility
- Annual merit increases
- Paid Time Off and Flexible Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
