Microbiology Technician III

JOB SUMMARY

Microbiology Technician III is a technical leader within the QC Microbiology function responsible for oversight and execution of Environmental Monitoring (EM), Personnel Monitoring, routine microbiological testing, and contamination control initiatives for GMP cleanrooms and supporting manufacturing/laboratory spaces. This role provides subject‑matter expertise (SME) in microbiology, oversees complex investigations, partners cross‑functionally to drive continuous improvement, and ensures all activities are conducted in alignment with cGMP, internal quality standards, and regulatory expectations. The Microbiology Technician III acts as a technical resource and may provide mentorship and training to junior microbiologists and technicians.

ESSENTIAL JOB FUNCTIONS

• Oversees and performs routine and non‑routine EM (viable air, surface, non‑viable particulates) with a high level of independence and technical accuracy.
• Interprets EM data trends; identifies adverse trends and contamination risks; initiates and drives improvement actions.
• Leads EM qualification activities and the development of new EM sampling locations, frequencies, and sampling strategies.
• Serves as SME for Environmental Monitoring, aseptic practices, and contamination control principles.
• Authors, reviews, and revises SOPs, protocols, and technical reports with minimal oversight.
• Leads or provides high‑level support to investigations (EM excursions, OOS, atypical results), including root‑cause analysis and CAPA creation.
• Supports audit readiness and may represent QC Microbiology during internal/external audits (e.g., FDA, clients).
• Supports Change Controls, CAPAs, Deviations, and associated documentation to ensure timely, compliant closure.
• Ensures adherence to aseptic technique, gowning, and environmental controls; provides coaching and corrective guidance when deviations are observed.
• Supports contamination prevention initiatives and partners with Manufacturing, Facilities, and QA to implement improvements.
• Trains new personnel on EM, microbiological assays, aseptic technique, and gowning.
• Serves as a technical resource for troubleshooting laboratory and EM issues.
• Participates in cross‑functional project teams including manufacturing support, quality initiatives, and facility expansion/qualification activities.
• Prepares and presents EM and microbiological data summaries to management and cross-functional teams.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

• B.S. degree in a scientific/technical discipline
• 5+ years of relevant industry experience in laboratory or clean room environment
• Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
• Strong expertise in microbiology, cleanroom behavior, EM programs, aseptic technique, and GMP expectations.
• Ability to independently interpret complex data sets and make science- and risk‑based decisions.
• Strong technical writing skills (SOPs, protocols, investigations, justification documents).
• Ability to lead without authority and mentor junior staff.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail