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Out client is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. They have a long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.
POSITION SUMMARY
The Microbiologist - Sterile is responsible for supporting sterile manufacturing operations by performing microbiological testing, environmental monitoring, and aseptic process support activities. This role ensures compliance with current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210/211, 820, ISO 13485, and EU Annex 1 requirements. The position plays a critical role in maintaining the microbiological control of aseptic processing environments used in the production of sterile injectable products.
ESSENTIAL FUNCTIONS
* Microbiology laboratory operations include ordering supplies, preparing media, disinfectant preparation, cleaning, operating laboratory equipment, sample receipt, documentation, following good documentation practices.
* Perform routine and specialized microbiological testing and assist senior microbiologist to support sterile manufacturing operations, including water, steam, and environmental monitoring programs.
* Conduct testing such as bioburden, endotoxin (LAL), sterility, biological indicators, and growth promotion in accordance with USP requirements.
* Execute environmental monitoring of classified cleanrooms and controlled environments, including viable air sampling and non-viable particulate monitoring, surface sampling (RODAC/contact plates and swabs), personnel monitoring.
* Support aseptic processing activities, including Gowning and working in classified cleanroom environments, monitoring aseptic operations for extended durations, Assisting with aseptic process simulations (media fills).
* Perform sampling and testing to support cleaning validation and verification programs, including swab and rinse sampling.
* Assist in process validation activities related to sterile manufacturing and aseptic processing.
* Perform microbial identification, gram staining, and evaluation of colony morphology.
* Maintain working knowledge and application of relevant USP chapters, including USP <51>, <61>, <62>, <71>, <85>, <1035>, and <1111>.
* Ensure proper documentation practices in compliance with GDP (Good Documentation Practices), including data recording, logbooks, and electronic systems.
* Support investigations related to out-of-specification, out-of-trend, and environmental monitoring excursions; assist in root cause analysis and corrective actions.
* Participate in trending and reporting of environmental and utility monitoring data.
* Prepare, review, and revise SOPs, protocols, reports, and risk assessments to ensure regulatory compliance.
* Maintain laboratory operations, including media preparation and inventory management, equipment cleaning, calibration coordination, and maintenance, disinfectant preparation and laboratory sanitation
* Support internal, customer, and regulatory audits.
* Coordinate sample shipment to contract laboratories and review test results for compliance.
* Ensure proper handling and disposal of biological and hazardous laboratory waste.
* Comply with all safety, GMP, and company policies while performing assigned duties.
* Collaborate cross-functionally with Quality, Manufacturing, and Validation teams to support sterile operations.
* Participate in Goods Receipt issuance for microbiology laboratory services as needed.
POSITION QUALIFICATIONS
* Excellent verbal and written communication skills with the ability to effectively present within all levels of the organization and clients.
* Flexibility to work weekends or extended hours as required by manufacturing schedules.
* Strong understanding of microbiological principles and sterile/aseptic manufacturing environments.
* Hands-on experience with microbiology testing, environmental monitoring in cleanroom environments.
* Familiarity with regulatory requirements for sterile manufacturing, including cGMP and EU Annex 1.
* Working knowledge of USP microbiological methods, especially USP <60>, <61>, <62>, <71>, and <1111>. Experience with endotoxin, sterility, and bioburden testing required.
* Knowledge of TOC, Conductivity, and Nitrate testing is a plus.
* Experience with quality systems and software such as TrackWise, SAP, MasterControl, and Novatek (stability software) is a plus.
* Ability to work independently with minimal supervision in a fast-paced, regulated environment.
* Handle hazardous and biological waste generated by microbiology laboratory.
* Adherence to regulatory/in-house requirements (may include but limited to safety, housekeeping, laboratory biological/chemical waste, cGMP, GLP, documentation) when performing assigned activity.
* Use of personal protective equipment to limit exposure to chemicals, biological or other hazards found within a laboratory environment.
* Ability to work collaboratively with other team members to ensure successful outcomes.
* Strong attention to detail and ability to produce accurate, compliant documentation.
* Proficiency in Microsoft Office applications (Word, Excel), and other laboratory information management systems.
EDUCATION: Bachelor"s degree in microbiology, Biology, or a related scientific discipline required. Equivalent experience may be considered.
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