Microbiology & Environmental Monitoring (EM) Supervisor

The Microbiology & Environmental Monitoring (EM) Supervisor leads the site's microbiology laboratory and contamination control program for sterile and non-sterile pharmaceutical manufacturing. The role ensures that cleanrooms, utilities, raw materials and products meet cGMP, FDA, EU GMP Annex 1 and USP requirements, and that microbial data is accurate, timely and inspection-ready.

Environmental monitoring program:

• Own the site EM program for classified areas (Grade A–D / ISO 5–8), including viable air, surface, personnel and non-viable particulate monitoring.

• Define and maintain sampling plans, locations, frequencies and alert/action limits using risk assessment.

• Lead trending of EM data and issue periodic EM reports with recommendations to Manufacturing and Quality.

• Support the site Contamination Control Strategy (CCS) in line with EU GMP Annex 1.

• Oversee cleanroom qualification and requalification support, including EM performance qualification after shutdowns.

Microbiology laboratory:

• Manage testing of utilities (WFI, purified water, clean steam, compressed gases) for bioburden and endotoxin.

• Oversee raw material, in-process and finished product testing: bioburden, microbial limits (USP <61>/<62>), sterility (USP <71>) and bacterial endotoxins (USP <85>).

• Manage microbial identification, culture media qualification and growth promotion testing.

• Lead method validation, method transfer and equipment qualification for the lab.

• Evaluate and implement rapid microbiological methods where they add value.

Compliance and investigations:

• Lead OOS, OOT and EM excursion investigations, including root cause analysis and CAPA.

• Own deviations, change controls and CAPAs for the microbiology function.

• Support aseptic process simulations (media fills) and disinfectant efficacy studies.

• Act as subject matter expert during regulatory inspections and customer audits; respond to observations.

• Write, review and approve SOPs, protocols and reports; ensure data integrity (ALCOA+).

Leadership:

• Hire, train and develop supervisors, analysts and EM technicians; set objectives and run performance reviews.

• Plan staffing and scheduling to meet testing and release timelines, including shift and weekend coverage.

• Manage the lab budget, supplies and contract testing labs.

• Train manufacturing staff on aseptic behavior, gowning and contamination control.

• Partner with Production, Engineering, QA and Validation on contamination risks and continuous improvement.

Required:

• Bachelor's degree in Microbiology, Biology or a related life science.

• 8+ years of pharmaceutical or biotech microbiology experience in a cGMP environment, including 3+ years managing people.

• Hands-on experience running an Environmental Monitoring program for aseptic or sterile manufacturing.

• Working knowledge of 21 CFR 210/211, EU GMP Annex 1, USP microbiology chapters and data integrity expectations.

• Track record of leading OOS and excursion investigations to defensible root cause.

• Direct experience with FDA or EMA inspections.

Preferre:

• Master's or PhD in Microbiology.

• Experience with rapid microbiological methods, MALDI-TOF identification or LIMS / EM data systems.

• Experience with sterile injectables, biologics or cell and gene therapy.

• Lean or Six Sigma training.

Skills:

• Clear technical writing for investigations, reports and regulatory responses.

• Ability to explain microbial risk to non-specialists and influence decisions.

• Strong organization and prioritization under release deadlines.

• Coaching style that builds capability and accountability in the team.

Working conditions:

• Regular work in laboratory and classified cleanroom areas, which requires full aseptic gowning.

• Exposure to microorganisms, disinfectants and laboratory chemicals under standard safety controls.

• Occasional off-hours or weekend support for excursions, investigations or inspections.

• Limited travel (under 10%) for training, conferences or supplier audits.