QC Environmental Monitoring Technician I

About the Role

The Environmental Monitoring Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals. This role plays a critical part in ensuring environmental control of the aseptic manufacturing facility.

Key Responsibilities

• Plan daily workload to meet requirements.
• Conduct environmental monitoring activities including air, surface, and personnel monitoring within the sterile manufacturing facility.
• Conduct water sampling throughout the facility.
• Record results and report deviation from specifications.
• Communicate any discrepancies or deviations to supervision/management upon discovery.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices (cGMPs), and health and safety requirements.
• Input data into a database and conduct trend analysis.
• Perform any other tasks/duties as assigned by management.

Requirements & Tech Stack

• High School Diploma or GED equivalent required.
• Associate Degree in microbiology, biology, or related scientific field preferred.
• Academic or industry work experience in a laboratory setting or manufacturing with a focus on microbiology preferred.
• Knowledge of aseptic technique preferred.
• Must be able to maintain Class 100 Certification for EM support.
• Ability to work independently with minimal supervision.
• Organization and attention to detail.
• Excellent communication skills (Oral and Written).
• Working knowledge of MS-Office software and PC Skills.
• Good work ethic and highly motivated.
• Ability to work in a fast-paced environment.
• Ability to work in a team-oriented environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Job activities require long periods of standing, use of controlled movements, and aseptic techniques/behaviors in sterile filling suites.