Enzene - Associate Scientist, Environmental Monitoring

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
We are seeking a QC Associate Scientist, Environmental Monitoring to be primarily responsible for executing and supporting routine and non-routine Environmental and Utility Monitoring in compliance with USP, EP, and FDA regulatory standards. This role also includes oversight and trending of environmental monitoring data and reports to support contamination control initiatives. The Associate Scientist will play a key role in leading contamination control activities for the site, collaborating with cross-functional teams to ensure proactive identification and mitigation of contamination risks. This role will include cross functional support of QC Microbiology Scientists for cGMP Microbiological testing including Growth Promotion testing, Bioburden testing, and Endotoxin (LAL) testing.

Key Responsibilities

• Quality Testing: Perform routine and dynamic environmental monitoring (EM) of cleanroom environments, including active viable air, passive air (settle plates), surface, and personnel sampling. Conduct utility sampling for Water for Injection (WFI), Clean Steam, Purified Water, and Compressed Gases. Perform microbial plate reading, CFU enumeration, and initial assessment of results, including identification of alert or action level excursions. Support QC Microbiology Scientists with bioburden, bacterial endotoxin, growth promotion, and microbial identification testing, including subculturing of environmental isolates. Ensure all sampling and testing activities follow current Good Manufacturing Practices (cGMP) and established internal standard operating procedures (SOPs).

• Equipment: Operate and maintain environmental monitoring equipment such as active air samplers, particle counters, compressed gas samplers, and microbiological incubators. Ensure all instruments are qualified, calibrated, and maintained. Assist with troubleshooting equipment and support root cause investigations related to sampling tools and laboratory instrumentation. Document equipment use and maintenance activities in accordance with company procedures.

• Troubleshooting: Author or assist with quality documentation for  EM and utility results excursions, sampling errors, or deviations from procedure. Lead and participate in root cause analyses, nonconformance investigations, and development of corrective and preventive actions (CAPAs) for EM and utility excursions. Implement changes related to EM procedures or equipment through change control activities.

• Data Analysis and Reporting: Perform data trending of viable and non-viable EM results to detect shifts or trends. Author periodic EM summary reports. Accurately complete all sample logs, test forms, notebooks, and other documentation following Good Documentation Practices (GDP). Document EM and utility data using LIMS or equivalent tracking tools. Familiarity with LIMS is preferred. Work closely with senior QC staff to ensure timely release of EM data.

• Collaboration: Coordinate closely with Manufacturing, Engineering, and QA staff to schedule and perform environmental and utility monitoring in support of production operations. Collaborate with QC Microbiology staff to perform routine and non-routine testing, troubleshoot EM deviations, and optimize sampling plans. Provide input and feedback during procedural updates and continuous improvement initiatives related to the EM program. Support team efforts during audit readiness activities and regulatory inspections.

• Training: Undergo a structured training program designed to develop technical proficiency, regulatory compliance awareness, and laboratory best practices. Observe and perform tasks independently including environmental monitoring, bioburden, endotoxin and growth promotion testing, and sample receipt.

Requirements

Qualifications

• Education: A bachelor’s degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology, Engineering or related discipline.  Advanced degrees are often preferred.

• Experience: 1-3 years of experience in a cGMP manufacturing or laboratory environment with environmental and utility monitoring and data trending experience required. A successful applicant should pos