Environmental Monitoring Technician

Job Title:

Environmental Monitoring Technician

Job Description

The Environmental Monitoring (EM) Technician supports the Quality Control Microbiology team by performing routine environmental and utility monitoring within GMP-regulated cleanroom environments. This role helps maintain cleanroom integrity, ensures adherence to regulatory requirements, and contributes directly to overall product quality. You will join a team that is building out a new environmental monitoring program, giving you the opportunity to help shape new processes and contribute to a growing function.

Responsibilities

+ Perform environmental monitoring of ISO-5, ISO-7, and ISO-8 clean rooms, including viable air, non-viable particulate, and surface sampling in accordance with established procedures.

+ Conduct utility sampling of systems such as WFI and RODI for bioburden and endotoxin testing to ensure water quality meets specifications.

+ Execute personnel gowning monitoring and support gowning qualification programs to verify compliance with aseptic practices.

+ Document all results accurately and completely in accordance with SOPs, cGMP, and GDP requirements.

+ Monitor cleanroom conditions, including pressure differentials, on a routine basis to maintain proper environmental controls.

+ Perform data entry, trending, and record maintenance for environmental monitoring activities, including analysis of EM data trends.

+ Support investigations related to deviations, out-of-specification (OOS) results, and non-conformances by providing EM data and technical input.

+ Prepare samples for internal and external laboratory testing, ensuring proper handling, labeling, and chain of custody.

+ Assist in the sterilization and cleaning of laboratory equipment to support a controlled and compliant laboratory environment.

+ Maintain inventory and manage the receipt of microbiological media and reagents to ensure continuous availability of supplies.

+ Participate in environmental monitoring program improvements, audits, and compliance activities by contributing observations and suggestions.

+ Collaborate cross-functionally with Quality Control, Quality Assurance, and Manufacturing teams to support production and quality initiatives.

+ Support additional QC microbiology or laboratory tasks as needed, including microbial sampling and testing.

+ Contribute to the build-out of a new environmental monitoring program and team by adopting new processes and supporting evolving team structures.

Essential Skills

+ Hands-on experience with environmental monitoring (EM) sampling, including viable and non-viable monitoring.

+ Practical knowledge of cleanroom operations in ISO 5-8 or Grade A-D environments.

+ Proficiency in aseptic technique and personnel gowning procedures.

+ Experience working under GMP, cGMP, and GDP requirements and following SOPs.

+ Ability to perform microbiological testing such as bioburden, endotoxin, and TOC.

+

Experience with surface, air, and personnel monitoring in controlled environments.

+ Knowledge of water system sampling, including WFI and RODI systems.

+ Capability to perform EM data trending and analysis to support investigations and continuous improvement.

+ Strong laboratory documentation skills, including accurate data entry and technical writing.

+ Experience supporting deviation, OOS, and CAPA activities through EM data and documentation.

+ Between 1 and 6+ years of experience in GMP, cleanroom, or environmental monitoring environments.

+ Experience working in ISO 5-8 environments or aseptic processing settings.

+ Familiarity with EM sampling techniques, including air sampling, water testing, bioburden testing, and microbial sampling.

+ Understanding and application of aseptic technique in a quality control or microbiology laboratory setting.

+ Associate's or Bachelor's degree in biology, microbiology, or a related scientific field.

Additional

Skills & Qualifications

+ Experience contributing to the development or expansion of an environmental monitoring program.

+ Comfort working closely with Quality Control, Quality Assurance, and Manufacturing teams in a regulated setting.

+ Ability to interpret and trend environmental monitoring data to identify patterns and support process improvements.

+ Strong attention to detail and adherence to documentation standards in a cGMP environment.

+ Effective communication skills for cross-functional collaboration and participation in audits and compliance activities.

Work Environment

This role is 100% onsite in a GMP-regulated facility with ISO 5-8 cleanroom environments and associated support areas. You will work primarily on the first shift, with a preferred start time of 8:00 a.m. or 9:00 a.m. to provide extended coverage into the late afternoon, and a standard 8-hour workday. The position involves frequent work inside controlled clean rooms, routine monitoring of viable and non-viable particulates, and regular interaction with water systems such as WFI and RODI.

You will use microbiological sampling tools, environmental…