Microbiology Technician III

Genezen • Indianapolis, IN

4d

About The Position

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.

Requirements

• 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.
• Criminal background check required

Responsibilities

• 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
• Other duties as assigned

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level