Microbiologist II Position Available In Middlesex, New Jersey

Job Description:

Job Title:

Microbiologist II Location:

Piscataway, New JerseyType:

Contract To Hire Hours:

Mon-Fri 8am-5pm

Position Summary:

Ourclient is seeking an experienced Microbiologist II to supportmicrobiology and environmental monitoring (EM) operations forsterile and non-sterile drug manufacturing. This full-time exemptrole requires 3-5 years of hands-on experience in a regulated cGMPlab setting. The ideal candidate brings subject matter expertise(SME) in aseptic techniques, water/EM testing, and microbialanalysis, and can lead or support lab investigations andcompliance-driven activities. You’ll also take ownership ofmicrobiology documentation, investigations, and trending whileworking 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 forviable/non-viable particles, oil, and moisture Conduct bioburden,microbial limits, gram stain, growth promotion, and endotoxintesting Review microbiology lab data and generate trend reports(Excel) Submit samples and isolates for external ID and testingOperate autoclaves, maintain lab equipment, and ensure sanitationlogs Lead or support investigations (OOS, alert/action levels,deviations) Generate and execute Change Controls related toprocedures, equipment, or methods Act as a document contributor inMasterControl for method/procedure updates

Minimum Qualifications:

Bachelor’s degree in Microbiology, Biology, or a related field 3-5years of hands-on cGMP microbiology lab experience in thepharmaceutical industry Proven experience performing EM, watertesting, and microbial assays Understanding of 21 CFR 210/211/820and cGMP microbiology requirements Experience using EM equipment(e.g., AirIdeal, Met One, Lasair III, MiniCapt) Comfortable withaseptic gowning, gown qualification, and cleanroom protocols Strongattention to detail, time management, and documentation practicesNice to

Have:

Experience with MasterControl, Veeva Vault, or otherQMS/document systems Participation in internal/external auditsAbility to lead or mentor junior microbiologists Familiarity withFDA inspection expectations System One, and its subsidiariesincluding Joulé, ALTA IT Services, and Mountain Ltd., are leadersin delivering outsourced services and workforce solutions acrossNorth America. We help clients get work done more efficiently andeconomically, without compromising quality. System One not onlyserves as a valued partner for our clients, but we offer eligibleemployees health and welfare benefits coverage options includingmedical, dental, vision, spending accounts, life insurance,voluntary plans, as well as participation in a 401(k) plan. SystemOne is an Equal Opportunity Employer. All qualified applicants willreceive consideration for employment without regard to race, color,religion, sex (including pregnancy, childbirth, or related medicalconditions), sexual orientation, gender identity, age, nationalorigin, disability, family care or medical leave status, geneticinformation, veteran status, marital status, or any othercharacteristic protected by applicable federal, state, or locallaw.