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Job Title: Microbiologist II

Type: Contract To Hire

Hours: Mon-Fri 8am-5pm

Position Summary:

Our client is seeking an experienced Microbiologist II to support microbiology and environmental monitoring (EM) operations for sterile and non-sterile drug manufacturing. This full-time exempt role requires 3–5 years of hands-on experience in a regulated cGMP lab setting. The ideal candidate brings subject matter expertise (SME) in aseptic techniques, water/EM testing, and microbial analysis, and can lead or support lab investigations and compliance-driven activities.

You’ll also take ownership of microbiology documentation, investigations, and trending while working cross-functionally with Quality and Manufacturing.

Responsibilities:

+ Perform environmental monitoring in ISO 5–8 areas (viable & non-viable sampling)

+ Conduct water testing: WFI, RO, purified water, and clean steam

+ Monitor compressed gases for viable/non-viable particles, oil, and moisture

+ Conduct bioburden, microbial limits, gram stain, growth promotion, and endotoxin testing

+ Review microbiology lab data and generate trend reports (Excel)

+ Submit samples and isolates for external ID and testing

+ Operate autoclaves, maintain lab equipment, and ensure sanitation logs

+ Lead or support investigations (OOS, alert/action levels, deviations)

+ Generate and execute Change Controls related to procedures, equipment, or methods

+ Act as a document contributor in MasterControl for method/procedure updates

Minimum Qualifications:

+ Bachelor’s degree in Microbiology, Biology, or a related field

+ 3–5 years of hands-on cGMP microbiology lab experience in the pharmaceutical industry

+ Proven experience performing EM, water testing, and microbial assays

+ Understanding of 21 CFR 210/211/820 and cGMP microbiology requirements

+ Experience using EM equipment (e.g., AirIdeal, Met One, Lasair III, MiniCapt)

+ Comfortable with aseptic gowning, gown qualification, and cleanroom protocols

+ Strong attention to detail, time management, and documentation practices

Nice to Have:

+ Experience with MasterControl, Veeva Vault, or other QMS/document systems

+ Participation in internal/external audits

+ Ability to lead or mentor junior microbiologists

+ Familiarity with FDA inspection expectations

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.