1 job for "Microbiology & Environmental Monitoring (EM) Supervisor"

Microbiology & Environmental Monitoring (EM) Supervisor

At Jabil - Hunt Valley

Posted on Oct 22

Microbiology & Environmental Monitoring (EM) Supervisor

Hunt Valley, MDPosted 19 days ago

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

How will you make an impact?

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.

What will you do?

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.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

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.

About Jabil

Made Possible. Made Better.

Size: 10,000+ employees
Industry: Manufacturing

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