Associate Scientist- Environmental Monitoring

Position Overview
The QC Associate Scientist, Environmental Monitoring will 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 authoring of monitoring 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 active air, passive air (settle plates), surface, non-viable particulates, 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. Assist with troubleshooting equipment and support root cause investigations related to sampling tools and laboratory instrumentation. Assist with onboarding new sampling equipment as required.
• Troubleshooting: Author or 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. EM summary reports and perform data trending of viable and non-viable EM and utility monitoring results to detect shifts or trends. Author periodic Work closely with senior QC staff to ensure timely release of monitoring 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. Participate in 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.
• Other duties as assigned.

Qualifications

• Education: An Associate’s (Bachelors degree is preferred) 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. Hands on experience with environmental monitoring and utility monitoring and data trending is preferred. A successful applicant should possess an understanding of cGMP and Quality Control in a pharmaceutical space.
• Skills: Hands on experience of environmental monitoring activities such as air (active/passive), surface, and personnel sampling, including water and gas utility testing and data analysis. 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 required. Must be able to speak clearly to convey information to others.  Timely follow-up and response is required.

  Physical Demands

• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.
• Must have clarity of vision for distances of 20 feet or more, necessary for recognizing hazards or reading signage.
• In addition to working a laboratory setting, 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 has repetitive motion repeated movements of the hands, wrists, or fingers, such as typing and using laboratory equipment.
• This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.

Salary Range: Min: $67,000 Max: $83,000 (Annual)

Benefits:

• Health Insurance Medical, Dental, Vision
• Life and AD&D Insurance
• Disability Insurance
• 401k Retirement Plan
• Paid Time Off (Vacation, Sick Leave, Holidays)

Equal Opportunity Employer: Enzene is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other status protected by applicable law.