Enzene - Environmental Monitoring Associate

Energy Vault; Hopewell (NJ); On-site; USD 60,000 - 75,000; Full time

Job summary

A leading biotech firm seeks a QC Environmental Monitoring Specialist to ensure adherence to standards in environmental and utility monitoring. This role includes tasks related to microbiological testing and requires collaboration with various departments while maintaining compliance with cGMP protocols. Ideal candidates should have relevant degrees and experience in biotech environments and a passion for quality control.

Qualifications

• 1-2 years of experience in a cGMP manufacturing or laboratory environment.
• Understanding of cGMP and Quality Control in pharmaceuticals.
• Knowledge of air, surface, and personnel sampling.

Responsibilities

• Support routine and non-routine Environmental and Utility Monitoring.
• Perform microbial plate reading and CFU enumeration.
• Assist with investigations and troubleshooting of monitoring results.

Skills

Environmental monitoring

Quality Control

Microbiology testing

Data analysis

Communication

Education

Associate’s degree in Microbiology or related field

Advanced degrees preferred

Tools

LIMS

Environmental monitoring equipment

Microbiological incubators

Job description

Job description

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 Environmental Monitoring Specialist 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 will include cross functional support 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 test method execution for 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: Assist with the investigation of out-of-specification (OOS) EM and utility results, sampling errors, or deviations from procedure. Participate in root cause analyses, nonconformance investigations, and development of corrective and preventive actions (CAPAs). Support implementation of changes related to EM procedures or equipment through participation in change control activities.
  
• Data Analysis and Reporting: 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. Assist with performing data trending of viable and non-viable EM results to detect shifts or trends. Assist with data generation for periodic EM summary reports. 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 under direct supervision including environmental monitoring, bioburden, endotoxin and growth promotion testing, and sample receipt.

Job requirements

Qualifications

• Education: An associate’s degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology, Engineering or related discipline. Advanced degrees are often preferred.
• Experience: 1-2 years of experience in a cGMP manufacturing or laboratory environment. Experience with environmental monitoring and utility monitoring is preferred. A successful applicant should possess an understanding of cGMP and Quality Control in a pharmaceutical space.
• Skills: Knowledge of or exposure to environmental monitoring activities such as air (active/passive), surface, and personnel sampling, including awareness of water and gas utility testing, is preferred. Ability and willingness to perform aseptic gowning and work in controlled cleanroom environments. Understanding of aseptic technique; hands-on experience within operation of monitoring equipment is preferred. Ability to adhere to cGMP sampling and testing procedures in compliance with internal SOPs and relevant cGMP guidelines. Able to input data and generate EM data trend charts. Understanding of microbiology test procedures including bioburden, endotoxin, and growth promotion testing is preferred. Familiarity with Microsoft Office applications and an understanding of electronic documentation or laboratory systems (e.g., LIMS, cGMP-compliant tools) is desirable.
• Communication: Strong verbal communication skills and documentation skills are preferred.

Physical Demands

• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.
• This job functions in an open office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets.
• This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.

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