Environmental Monitoring Scientist I

TekWissen•Greenville, NC

3d•Onsite

About The Position

The Environmental Monitoring Scientist I is responsible for performing Environmental Monitoring (EM) activities within classified cleanrooms supporting sterile manufacturing operations. This role involves routine and non-routine viable and non-viable environmental sampling, processing and reviewing EM data, and supporting the assessment and maintenance of cleanroom environmental conditions in compliance with GMPs, approved procedures, data integrity principles, and site quality standards. The position collaborates closely with Manufacturing, Quality Assurance, Microbiology, and other cross-functional teams to support compliant manufacturing operations.

Requirements

Bachelor's degree in Biology, Microbiology, Biochemistry, or a related scientific discipline preferred; equivalent education, training, and relevant experience may be considered.
Previous experience in Environmental Monitoring, cleanroom operations, aseptic manufacturing, pharmaceutical manufacturing, or another regulated environment is preferred but not required.
Basic understanding of scientific principles, Environmental Monitoring techniques, cleanroom practices, and GMP requirements.
Ability to accurately follow detailed procedures, SOPs, sampling instructions, and established practices in a regulated environment.
Strong attention to detail with a commitment to accurate and timely documentation.
Strong organizational, problem-solving, and critical-thinking skills.
Ability to review data, recognize atypical results or conditions, and appropriately communicate or escalate potential issues.
Proficiency with Microsoft Office, particularly Excel and Word; experience with LIMS, Environmental Monitoring systems, or similar databases is a plus.
Effective written and verbal communication skills and ability to collaborate with cross-functional teams.
Ability to work independently within established procedures and recognize when additional guidance or escalation is required.
Ability to work effectively in a fast-paced manufacturing environment and adapt to changing priorities.
Ability to perform basic mathematical calculations and data analysis.
Ability to work in classified cleanroom environments while wearing required PPE and cleanroom garments for extended periods.
Ability to stand and walk for prolonged periods and perform routine sampling activities within laboratory, manufacturing, and classified cleanroom areas.
Ability to handle equipment and materials and perform sampling activities requiring routine hand and arm dexterity.

Nice To Haves

Previous experience in Environmental Monitoring, cleanroom operations, aseptic manufacturing, pharmaceutical manufacturing, or another regulated environment.
Experience with LIMS, Environmental Monitoring systems, or similar databases.

Responsibilities

Perform routine and non-routine Environmental Monitoring sampling within classified cleanroom areas.
Conduct viable and non-viable environmental monitoring activities according to approved procedures and sampling plans.
Collect, document, process, and maintain Environmental Monitoring samples and associated data accurately and on time.
Review EM results against established specifications, alert/action levels, and acceptance criteria.
Identify, document, and escalate excursions, atypical results, and other environmental concerns.
Perform data entry, calculations, data processing, and documentation in applicable laboratory and Environmental Monitoring systems.
Support review and evaluation of EM data to assess the ongoing state of control of classified cleanrooms.
Provide Environmental Monitoring oversight of assigned classified areas.
Observe environmental conditions and identify and communicate potential issues or concerns.
Support investigations related to EM excursions, deviations, and other quality events by providing accurate data, documentation, and technical input.
Follow applicable SOPs, sampling procedures, GMP requirements, and Environmental Monitoring program expectations.
Ensure EM activities and documentation comply with GMP requirements, data integrity principles, and site procedures.
Operate and maintain Environmental Monitoring equipment and supplies according to established procedures.
Identify and appropriately escalate equipment or procedural issues.
Collaborate with Manufacturing, Quality Assurance, Microbiology, and other cross-functional teams.
Complete documentation and records accurately, contemporaneously, and in accordance with procedures.
Organize and manage assigned activities to meet established timelines and operational requirements.
Complete required safety, quality, GMP, and job-specific training.
Follow established safety requirements, cleanroom gowning procedures, and aseptic practices.
Perform additional duties and responsibilities as assigned by area supervision.