Job Description
Microbiologist III – Penn Life Sciences
Pay Range: $85,000–$99,000/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 III serves as a senior technical expert within the Microbiological Services department, providing advanced scientific and regulatory support to ensure sterility assurance and microbiological control across Penn Life Sciences’ aseptic manufacturing operations. This role is responsible for leading complex laboratory testing, mentoring junior staff, and driving continuous improvement initiatives in contamination control, data integrity, and method validation.
Key Responsibilities:
• Perform and review complex microbiological assays on raw materials, in-process samples, finished products, and stability batches, including sterility, endotoxin, bioburden, and antimicrobial effectiveness testing.
• Lead and oversee environmental monitoring programs, including viable and nonviable cleanroom monitoring, personnel qualification, and utility testing (WFI, purified water, compressed air, nitrogen).
• Analyze and trend microbial and particulate data to detect adverse patterns and propose corrective actions.
• Plan, execute, and document microbiological qualification and validation studies for sterilization, depyrogenation, cleaning, and aseptic process simulations (media fills).
• Author, review, and approve investigations, deviations, and CAPAs related to microbiological events and aseptic process deviations.
• Develop, revise, and approve laboratory SOPs, methods, forms, and technical reports to ensure alignment with regulatory expectations.
• Mentor and train microbiologists on aseptic technique, documentation practices, and contamination control principles.
• Review laboratory data, notebooks, and electronic records for accuracy, completeness, and compliance with SOPs and data integrity requirements.
• Serve as a subject matter expert (SME) during internal and external regulatory inspections and audits.
• Collaborate cross-functionally with QA, Production, Facilities, and Validation to maintain aseptic control and audit readiness.
• Support continuous improvement initiatives to strengthen microbiological processes, reduce contamination risks, and enhance laboratory efficiency.
• Ensure laboratory safety, proper equipment maintenance, and inventory control in compliance with internal and external requirements.
What We’re Looking For
Experience: 7–10 years of microbiology or quality control laboratory experience in a GMP-regulated pharmaceutical, biotechnology, or sterile manufacturing environment.
Education: Bachelor’s degree in Microbiology, Biology, Biochemistry, or related life-science discipline required; Master’s degree preferred.
Skills & Knowledge:
• Expert knowledge of microbiological techniques, contamination control, and aseptic manufacturing principles.
• Strong working understanding of 21 CFR Parts 210–211, USP <61> , <62> , <71> , <85> , and related microbiological standards.
• Proficiency with LIMS, MODA, and electronic laboratory documentation systems.
• Advanced ability to interpret complex analytical data and identify trends, anomalies, and root causes.
• Experience developing and validating microbiological test methods and qualification protocols.
• Excellent written and verbal communication skills, including report authorship and regulatory correspondence.
• Proven leadership and mentoring capability within a technical or regulated laboratory setting.
• Ability to manage multiple priorities independently and maintain composure under inspection or audit conditions.
• Willingness to work occasional evenings, weekends, or overtime to support validation or production activities.
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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