Microbiology & Environmental Monitoring (EM) Supervisor

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.

How will you get here?

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.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

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Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

Client-provided location(s): Hunt Valley, MD

Job ID: Jabil-J2466980

Employment Type: FULL_TIME

Posted: 2026-10-23T00:49:13