Perform Environmental Monitoring activities within classified cleanrooms supporting sterile manufacturing operations. Execute routine and non-routine environmental sampling, process and review generated data, and support the assessment of cleanroom environmental conditions in accordance with approved procedures, Good Manufacturing Practices (GMPs), and site quality standards.
Qualifications
- Bachelor’s degree in Biology, Microbiology, Biochemistry, or a related scientific discipline is preferred; however, an equivalent combination of education, training, and relevant experience will 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 and the ability to learn Environmental Monitoring techniques, cleanroom practices, and applicable GMP requirements.
- Ability to accurately follow detailed procedures, sampling instructions, and established practices in a regulated environment.
- Strong attention to detail with a commitment to accurate, complete, and timely documentation.
- Strong organizational, problem-solving, and critical-thinking skills.
- Ability to review data, recognize atypical results or conditions, and appropriately communicate and elevate potential issues.
- Proficiency with Microsoft Office applications, including Excel and Word; experience with laboratory information management systems (LIMS), Environmental Monitoring systems, or similar databases is a plus.
- Effective written and verbal communication skills and the ability to work collaboratively with cross-functional teams.
- Ability to work effectively in a fast-paced manufacturing environment, manage assigned responsibilities, and adapt to changing priorities.
- Ability to perform basic mathematical calculations and data analysis.
- Ability to work independently within established procedures while recognizing when additional guidance or escalation is appropriate.