Job Description
Microbiologist II – Penn Life Sciences
Pay Range: $70,000–$85,000/year (Full-time, Exempt)
Location: Langhorne, PA
Department: Microbiological Services
About Penn Life Sciences
Penn Life Sciences is a rapidly expanding sterile injectable and ophthalmic pharmaceutical manufacturer dedicated to ensuring the highest standards of safety, quality, and compliance. Located in Langhorne, Pennsylvania , our facility operates under strict FDA and global cGMP regulations, utilizing cutting-edge technologies to support sterile manufacturing and analytical services. Our mission is to advance patient well-being through the development and production of reliable, life-saving medications — driven by integrity, innovation, and scientific excellence.
What You’ll Do
The Microbiologist II performs advanced microbiological testing and analytical activities to support sterile and oral solid dosage manufacturing operations. This role applies technical expertise to ensure sterility assurance, contamination control, and regulatory compliance across all microbiological programs. The incumbent will support laboratory operations, environmental monitoring, validation, and method development initiatives while maintaining data integrity and adherence to cGMP standards.
Key Responsibilities:
• Perform microbiological assays including bioburden, endotoxin, sterility, antimicrobial effectiveness, and microbial limits testing on raw materials, in-process samples, and finished products.
• Execute environmental and personnel monitoring for aseptic manufacturing areas and utilities (WFI, purified water, compressed gases, and cleanroom air).
• Perform microbial isolation and identification using conventional and rapid microbiological methods.
• Conduct gowning qualifications, cleanroom monitoring, and microbial trending to maintain aseptic process control.
• Support validation studies for sterilization, depyrogenation, cleaning, and aseptic process simulations (media fills).
• Participate in laboratory investigations, deviations, and OOS/OOT events with sound scientific reasoning and documentation.
• Review microbiological data, reports, and test results for accuracy and compliance prior to submission.
• Draft, revise, and implement SOPs, protocols, and technical documents to enhance laboratory efficiency and quality standards.
• Assist in equipment qualification, calibration verification, and preventive maintenance activities.
• Maintain laboratory inventory, cleanliness, and safety compliance in accordance with internal and external regulatory standards.
• Mentor and train junior microbiologists under the guidance of management.
• Ensure all documentation is contemporaneous, traceable, and compliant with ALCOA+ data integrity principles.
• Support risk assessments, CAPAs, and continuous improvement efforts in microbiological control programs.
What We’re Looking For
Experience: 3–6 years of microbiological or quality control laboratory experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
Education: Bachelor’s degree in Microbiology, Biology, Biochemistry, or related life science discipline required; Master’s degree preferred.
Skills & Knowledge:
• Comprehensive understanding of microbiological principles, aseptic gowning, and contamination control.
• Proficiency in environmental monitoring, sterility testing, and microbial identification methods.
• Experience with LIMS, MODA, or equivalent laboratory data systems.
• Strong analytical and documentation review capabilities with keen attention to detail.
• Excellent written and verbal communication skills with the ability to collaborate across departments.
• Ability to manage multiple priorities independently while maintaining compliance and accuracy.
• Strong organizational, technical troubleshooting, and problem-solving skills.
• Willingness to work occasional evenings or overtime to support production schedules.
What We Offer
• Competitive salary with annual performance bonus eligibility
• Annual merit-based salary increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• PTO accrual: 10 days per year (standard) or 15 days per year (management)
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Career advancement and technical growth opportunities within the microbiology and quality organizations
• Professional development reimbursement
• Tuition reimbursement for children and childcare expense reimbursement
Schedule
• Full-time, on-site position (Monday–Friday, day shift; flexibility required to support production and environmental monitoring schedules)
Company DescriptionPenn Life Sciences
Penn Life Sciences
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