Environmental Monitoring Technician

Role Summary

The Environmental Monitoring Technician performs routine environmental monitoring to assess viable and nonviable particulate levels within classified manufacturing rooms and support rooms.

Responsibilities

• Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas (Compounding, Component Preparation, Vial Wash, and Dispensary)
• Collect facility waters and submit for testing and accurately record results of above testing and promptly report any discrepancies or out of limit conditions to supervisor
• Perform Aseptic Gowning Training and certification sampling
• Requisition of materials, maintaining inventory and receive and store prepared media
• Prepare environmental monitoring plates and EM test reports for aseptic processing area
• Perform disinfection of incubator rooms weekly
• Follow safety requirements and maintains good housekeeping of laboratory area
• Incubate and inspect media fill units and incubate and examine samples for microbial growth
• Enumerate bacteria and report excursions
• Temperature charts for incubators and refrigerators in the Microbiology Laboratory
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP‚Äôs, FDA, OSHA and other regulatory agencies.
• Assume additional duties and responsibilities as assigned

Qualifications

• Bachelor‚Äôs degree in Chemistry, Microbiology, Biology or other related Science from an accredited university required
• May consider an Associate‚Äôs degree from an accredited university with minimum 3 (three) years of experience in the pharmaceutical industry (cGMP environment) and aseptic technique
• May consider a High School Diploma with minimum 5 (five) years of experience in the pharmaceutical industry (cGMP environment) and aseptic technique
• Minimum 1 (one) year experience in the pharmaceutical industry (cGMP environment) and aseptic technique
• Ability to get gowning certified within 30 days
• Physical Requirements include - standing and walking up to 8 hours (4 hours at a time for aseptic processing area), lifting or moving up to 35 pounds and reaching with hands and arms up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl up to 1 hour.
• Must be flexible for working across shifts (nights and/or weekends) as needed

Skills

• A ‚ÄòSee it, Own it, Make it Happen‚Äô attitude
• Excellent problem solving and critical thinking skills
• Strong attention to detail and ability to follow standard procedures
• Team collaboration and professional behaviors to align with guiding principles and core values
• Good interpersonal and communication skills