Environmental Monitoring Scientist I

Environmental Monitoring Scientist I; Greenville (NC); On-site; USD 32,000 - 47,000; Full time

Job summary

TekWissen Group is seeking an Environmental Monitoring Scientist I for a 12-month onsite assignment in Greenville, NC. The role focuses on performing environmental monitoring in classified cleanrooms supporting sterile manufacturing operations and ensuring data integrity and GMP compliance.

You will conduct sampling, review EM data, and collaborate with Manufacturing, Quality Assurance, and Microbiology to maintain control of cleanroom environments and support investigations as needed.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry or related field is preferred.
• Experience in Environmental Monitoring, cleanroom operations or regulated environments is preferred but not required.
• Ability to follow detailed SOPs, sampling instructions, and GMP procedures.

Responsibilities

• Perform routine and non-routine Environmental Monitoring sampling in classified cleanrooms.
• Conduct viable and non-viable EM monitoring according to procedures and plans.
• Collect, document, process, and maintain EM samples and data accurately and timely.
• Review EM results against specifications and acceptance criteria.
• Identify, document, and escalate excursions or atypical results.
• Enter data, perform calculations, and document in EM systems.
• Support EM data review to assess state of control of cleanrooms.
• Collaborate with Manufacturing, QA, Microbiology and cross-functional teams.

Skills

Attention to detail

Organizational skills

Problem-solving

Communication

Education

Bachelor's degree in Biology/Microbiology/Biochemistry or related field

Tools

Excel

Word

LIMS

Environmental Monitoring systems

Job description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position:

Environmental Monitoring Scientist I

Location: Greenville, NC 27834

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift & Training Schedule

• Regular Shift: B Shift - 6:00 PM to 6:00 AM, rotational schedule.


• The schedule will consist of alternating workdays. For example, one week may be Sunday, Wednesday, and Thursday, followed by Monday, Tuesday, Friday, and Saturday the following week.


• Training Schedule: Selected candidates will complete training on the Monday–Friday day shift, 8:00 AM to 5:00 PM.


• Candidates must be available to work the designated training schedule before transitioning to the regular B Shift.

Summary

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

Key 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 elevate 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 elevate 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.

Qualifications

• 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 elevate 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.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.