Environmental Monitoring Technician
About The Position
Penn Life Sciences is seeking an Environmental Monitoring Technician to join our team in Langhorne, PA. The Environmental Monitoring Technician will perform routine and non-routine environmental monitoring (EM) activities to support sterile injectable manufacturing operations. This role ensures the aseptic processing areas remain in a state of environmental control through accurate sampling, documentation, and interpretation of viable and non-viable data. The ideal candidate will demonstrate strong attention to detail, adherence to procedures, and commitment to maintaining compliance with FDA, EU, and global regulatory standards in a cGMP-controlled environment.
Requirements
- High school diploma or equivalent required; associate's or bachelor's degree in Microbiology, Biology, or a related life science preferred.
- 0-3 years of experience in pharmaceutical, biotechnology, cleanroom, or laboratory environments (prior EM or aseptic experience preferred but not required).
- Ability to follow aseptic techniques, gowning procedures, and written instructions with precision and consistency.
- Strong attention to detail, data accuracy, and documentation integrity.
- Effective communication skills and proficiency with basic computer applications (Microsoft Office, data entry).
- Willingness to work overtime, weekends, or alternate shifts as needed to support sterile manufacturing operations.
- Must successfully complete aseptic gowning qualification and training as part of role requirements.
Responsibilities
- Perform viable and non-viable particulate monitoring within classified cleanrooms and controlled environments.
- Collect EM, personnel, utility, and equipment samples following approved SOPs and cGMP documentation practices.
- Record, verify, and review environmental data in accordance with GDP and ALCOA+ principles.
- Identify and escalate atypical or out-of-limit results to support proactive contamination control.
- Maintain, calibrate, and prepare monitoring equipment and supplies for daily use.
- Support data trending, analysis, and reporting to assist with routine reviews and site quality metrics.
- Participate in aseptic process simulations, gowning qualifications, and cleaning validation studies as required.
Benefits
- 401(k) with company match
- Health, vision, and dental Insurance
- Childcare expense reimbursement
- Tuition reimbursement
- Annual bonus eligibility
- Annual merit increases
- Paid Time Off and Flexible Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
11-50 employees
