Aseptic Environmental Monitoring Technician

American Regent, Inc.; Shirley (MA); On-site; USD 32,000 - 34,000; Full time

Benefits offered by this job

Healthcare

Profit sharing

Paid time off

401k matching

Job summary

American Regent, Inc. is seeking an Environmental Monitoring Team I to conduct environmental monitoring within the aseptic manufacturing facility, including air, water, surfaces, and personnel sampling, while ensuring compliance with SOPs and cGMPs.

The role supports data capture in Labware LIMS, maintains documentation, and collaborates with manufacturing to maintain environmental control and safety standards.

Qualifications

• High School Diploma or GED; Associate degree in microbiology, biology or related field preferred.
• One year experience in academic or industry lab or manufacturing with focus on microbiology preferred.
• Knowledge of aseptic technique preferred.
• Must maintain APA gown qualification for EM support.
• Ability to perform basic mathematical calculations.
• Ability to work independently and as a team with minimal supervision.
• Strong organization and attention to detail.
• Excellent communication skills (oral and written).
• Working knowledge of MS-Office software and PC skills required.
• Good work ethic and highly motivated.
• Good time-management skills.
• Ability to work in a fast-paced environment.
• Must be able to read Standard English SOPs and manuals.
• Ability to work overtime, weekends and holidays as needed.

Responsibilities

• Ensure all work is performed and documented in accordance with company policies, cGMPs, and health and safety requirements.
• Manage daily workload to meet requirements and perform sampling as per schedule.
• Complete gowning qualifications for EM support and aseptic areas.
• Perform environmental monitoring including sampling of air, surface, water, and personnel.
• Conduct water sampling throughout facility.
• Complete incubation, transfer and final readings of samples.
• Record results and report deviations per specifications.
• Capture sampling life cycles in the LIMS software and assist with data entry for retrieval and trending from Labware LIMS.
• Maintain accurate records in Labware LIMS and documentation systems according to SOPs.
• Maintain compliance with all SOPs and policies.
• Communicate discrepancies or deviations to supervision/management.
• Assist with data collection for assigned EM/PM investigation reports.
• Perform clean room behavior and area assessments as needed.
• Review environmental and personnel monitoring results in Labware LIMS as needed.
• Input data/results into database and perform trend analysis.
• Perform other tasks/duties as assigned by management.

Skills

Communication skills

MS-Office

Time management

Teamwork

Education

High School Diploma or GED

Associate degree in microbiology/biology

Tools

Labware LIMS

Job description

American Regent, Inc. is seeking an Environmental Monitoring Team I to conduct environmental monitoring within the aseptic manufacturing facility, including air, water, surfaces, and personnel sampling, while ensuring compliance with SOPs and cGMPs.

The role supports data capture in Labware LIMS, maintains documentation, and collaborates with manufacturing to maintain environmental control and safety standards.