The Analytical Research and Development Microbiology group in Rahway, New Jersey, is seeking an onsite, first-shift Scientist (Microbiologist). This role offers the opportunity to join a global, multidisciplinary team dedicated to improving human health through exceptional science, robust ethics, and diverse collaborative experiences. Operating within a fast-paced, good manufacturing practices (GMP) environment, the successful candidate will drive a rapidly growing pipeline by delivering critical microbiological data and collaborating with cross-functional stakeholders. The position is ideal for a self-motivated professional looking to expand their career while maintaining high standards of data integrity and regulatory compliance.
Responsibilities- Environmental Monitoring (EM): Perform routine viable and non-viable EM in classified cleanrooms (Grades A-D), including surface, air, and equipment sampling.
- Aseptic Sampling & Utilities: Execute precise aseptic sampling techniques for compressed gases, clean steam, and water systems (WFI, purified water) to ensure contamination-free data collection.
- Microbiological Testing: Conduct bioburden, endotoxin, microbial identification, microbial enumeration, and biological indicator (BI) testing, utilizing isolators for sterility and method suitability testing.
- Instrumentation & Maintenance: Operate and maintain specialized EM equipment, including particle counters, viable air samplers, and isolator/BSC sampling tools.
- Data Analysis & Review: Trend and interpret EM data, execute second-scientist reviews of microbiology experiments, and ensure strict compliance with ALCOA and data-integrity principles.
- Investigations & Quality Compliance: Escalate out-of-trend (OOT) results, participate in deviation investigations, perform root-cause assessments, and support CAPA development.
- Cross-Functional Collaboration: Partner with Quality, Pipeline, and Operations stakeholders, and support both internal and external regulatory compliance audit activities.
- Operational Support: Manage laboratory inventory, accurately document experimental procedures/conclusions, and maintain flexibility for weekday shifts and weekend support as required.
Education- Minimum Requirement: Bachelor of Science (BS) or Master of Science (MS) degree in Microbiology, Biological Sciences, or a closely related discipline.
Experience Required- Industry Experience: Minimum of 2 years of pharmaceutical industry experience with an MS degree, or 3 years with a BS degree, featuring direct microbiological testing in a GMP environment.
- Technical Knowledge: Proven expertise in environmental monitoring, aseptic manufacturing, utilities testing, and standard compendial microbiology guidelines.
- Core Competencies: Demonstrated proficiency in aseptic techniques, laboratory information management, problem-solving, and professional interpersonal communication.
Preferred- Advanced Manufacturing: Experience with sterile, non-sterile, and aseptic manufacturing product testing.
- Quality Systems: Proven track record of supporting quality investigations within the microbiology discipline.
- Digital Tools: Prior hands-on experience with industry-standard software such as MODA, SAP, Veeva, or LIMS.
Additional Information- Location & Shift: Full-time, onsite position at the Rahway, New Jersey facility, operating on the first shift.
- Schedule Flexibility: Candidates must be adaptable to shifting weekday hours and occasional weekend coverage based on business and operational needs.
