Microbiology & Environmental Monitoring (EM) Supervisor

Jabil•Hunt Valley, MD

20h•$81,400 - $146,500

About The Position

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. The supervisor owns the site environmental monitoring program for classified areas, oversees microbiological testing and laboratory methods, and leads compliance activities and investigations. The role also manages and develops laboratory and EM personnel, budgets, schedules, supplies, and contract testing labs, while partnering with Production, Engineering, QA, and Validation on contamination risks and continuous improvement. Regular work takes place in laboratory and classified cleanroom areas and requires full aseptic gowning. The position may require occasional off-hours or weekend support and limited travel under 10%.

Requirements

Bachelor's degree in Microbiology, Biology, or a related life science.
At least 8 years of pharmaceutical or biotech microbiology experience in a cGMP environment, including at least 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.
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.

Nice To Haves

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.

Responsibilities

Own the site environmental monitoring program for classified areas, 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 environmental monitoring data and issue periodic reports with recommendations to Manufacturing and Quality.
Support the site Contamination Control Strategy in line with EU GMP Annex 1.
Oversee cleanroom qualification and requalification support, including environmental monitoring performance qualification after shutdowns.
Manage testing of utilities, including WFI, purified water, clean steam, and compressed gases, for bioburden and endotoxin.
Oversee raw material, in-process, and finished product microbiological testing, including bioburden, microbial limits, sterility, and bacterial endotoxins.
Manage microbial identification, culture media qualification, and growth promotion testing.
Lead method validation, method transfer, and laboratory equipment qualification.
Evaluate and implement rapid microbiological methods where they add value.
Lead OOS, OOT, and environmental monitoring 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 a subject matter expert during regulatory inspections and customer audits, and respond to observations.
Write, review, and approve SOPs, protocols, and reports; ensure data integrity (ALCOA+).
Hire, train, and develop supervisors, analysts, and environmental monitoring technicians; set objectives and conduct performance reviews.
Plan staffing and scheduling to meet testing and release timelines, including shift and weekend coverage.
Manage the laboratory budget, supplies, and contract testing laboratories.
Train manufacturing staff on aseptic behavior, gowning, and contamination control.
Partner with Production, Engineering, QA, and Validation on contamination risks and continuous improvement.

Benefits

Competitive base salary.
Medical, dental, prescription drug, and vision insurance with HRA and HSA options.
401K match.
Employee Stock Purchase Plan.
Paid Time Off.
Tuition Reimbursement.
Life, AD&D, and disability insurance.
Commuter Benefits.
Employee Assistance Program.
Pet Insurance.
Adoption Assistance.
Annual Merit Increases.
Community Volunteer Opportunity.
Paid parental leave.
Company-paid holidays, subject to change yearly.