Enzene Biosciences Ltd · 14 hours ago
Associate Scientist- Environmental Monitoring
Pennington, NJ
Full-time
Onsite
Entry Level
$67K/yr - $83K/yr
1+ years expEnzeneinc is seeking an Associate Scientist for Environmental Monitoring to ensure compliance with regulatory standards in a laboratory setting. The role involves executing environmental and utility monitoring, collaborating with cross-functional teams, and supporting contamination control initiatives.
BiotechnologyDeliveryManufacturing
Responsibilities
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)
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
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
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
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
Qualification
Required
An Associate's degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology, Engineering or related discipline
1-2 years of experience in a cGMP manufacturing or laboratory environment
Hands on experience with environmental monitoring and utility monitoring and data trending
Understanding of cGMP and Quality Control in a pharmaceutical space
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
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
Strong verbal communication skills and documentation skills
Preferred
A Bachelor's degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology, Engineering or related discipline
Hands on experience with environmental monitoring and utility monitoring and data trending
Familiarity with LIMS
Understanding of microbiology test procedures including bioburden, endotoxin, and growth promotion testing
Familiarity with Microsoft Office applications and an understanding of electronic documentation or laboratory systems (e.g., LIMS, cGMP-compliant tools)
Benefits
Health Insurance Medical, Dental, Vision
Life and AD&D Insurance
Disability Insurance
401k Retirement Plan
Paid Time Off (Vacation, Sick Leave, Holidays)
Company
Enzene Biosciences Ltd
Enzene an integrated global CDMO offers services spanning discovery, development and commercial supply.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$50.26M2023-01-30Series Unknown· $50.26M
Leadership Team
Lourdes Gonzalez-Novo, MBA
Chief Commercial Officer (CCO)
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