Microbiologist II Position Available In Passaic, New Jersey

Job Description:

Title Microbiologist II, RCM Location Totowa, New JerseyDepartment Radiopharmaceutical Contract Manufacturing Overview TheMicrobiologist II /Environmental Monitoring Specialist (EMS)supports manufacturing activities at the RCM-NJ5 site by (1)detecting, quantifying, identifying and investigating possiblecontaminants that may impact the quality of product duringdifferent stages of the manufacturing process, (2) establishing andmonitoring the state of microbiological control at the site, and(3) assessing aseptic behavior and practices of site personnel andassessing the effectiveness of cleaning and sanitization programsat the site. Essential Duties and Responsibilities ? Responsiblefor the site environmental monitoring (EM) program by maintainingsampling schedules in accordance with procedures, performingsampling of rooms, equipment and personnel. ? Perform EM samplemanagement in LIMS in addition to all media / sample growthpromotion, subsequent incubations, result reads/ interpretation,isolate ID, and completion of EM documentation. ? Initiate andperform investigations as directed, determine root cause andprovide expert guidance on required corrective actions for EMexcursions. Evaluate EM results for trends that may indicatedeclining microbiological control of the GMP productionenvironment. ? As directed, draft / revise / review SOP’s,protocols, and implement procedures, specifications, processes, andmethods as required. ? Peer review the work of other MicrobiologistII, Microbiologist I, EM Tech, or QC Tech. ? Provide training tojunior Microbiologist and EM technicians or designees. ? Identifyand perform stability and microbiology lab improvements: assist inor lead any such improvement projects. ? Assist in businessenhancements opportunities such as establishing growth promotionand isolate ID programs at NJ5. Become an expert on workflow fornew capabilities and train junior microbiologists and EM techs. ?Serve as backup to all responsibilities of MicrobiologistIII/Manager and relevant microbiology personnel. ? Attend meetingsand 1:1s with Microbiology / QC management. ? Support finishedproduct release by performing sterility, endotoxin, and particulatematter testing (as required). Perform basic QC testing as required.? Maintain initial and annual gowning validation and otherqualifications as necessary. This includes initial training andretraining for aseptic gowning. ? Support aseptic processsimulation activities by participating in media fills to enter ISO7 production areas and ISO 5 enclosures. ? Coordinate allsubcontracted B/F, growth promotion and isolate ID activities,including sample control and tracking, defining testingrequirements, and assuring subcontracted laboratories are aware oftarget completion dates. ? Test method development, transfer, andvalidation projects. ? Support inventory management program for EM,Media fills and release testing materials and consumables.

Continuously work with Production personnel / Schedular andwarehouse manager to order and maintain adequate inventory at alltimes. Manage external laboratory program for the department. ?Perform sterility failure and media fill failure investigations, ifneeded. Perform other sterility assurance and microbiology relatedinvestigations. ? Support lab audits, gemba and safety walkthroughs as the site Microbiology expert. ? Ensure data integrityand compliance of all microbiology testing equipment, incubators,and laboratory. ? Review job relevant trends (e.g. environmentalmonitoring, cleaning, sanitization, etc.) to initiate correctiveand preventive actions and/or for continuous process improvement. ?Conduct review of aseptic operations to ensure compliance tointernal procedures (e.g. gowning, cleaning, sanitation, sterility,environmental monitoring, etc.) and USP/FDA regulations. ? Ensurecompliance to all applicable standard operating procedures andregulations, including 21 CFR Part 211 and Eudralex Volume 4requirements. ? Other responsibilities as required. Qualifications? Bachelor’s Degree in a Life Science discipline (B.Sc. inmicrobiology or biology preferred) and 5 years in a cGMPlaboratory/ production environment including performingenvironmental monitoring, or Master’s Degree in a Life Sciencediscipline (microbiology or biology preferred) and 3 years in acGMP laboratory/ production environment including performingenvironmental monitoring. ? Knowledge of USP, FDA, and cGMPregulations preferred. ? Knowledge of how and ability to write,review, and revise SOPs required. ? Ability to read, analyze, andinterpret governmental regulations, professional journals, ortechnical procedures required. ? Ability to read and interpretdocuments such as safety rules, operating and maintenanceinstructions, and procedure manuals required. ? Ability toeffectively present information, deliver training, and respond toquestions from groups of managers, clients, customers, and thegeneral public required. ? Ability to define problems, collectdata, establish facts and draw valid conclusions required. ?Ability to make critical decisions backed by data. ? Ability tosolve problems and handle issues required. ? Proficiency in MSOffice applications required. ? Strong interpersonal communicationskills for interacting with site personnel, inspectors, andinternal and external vendors required. ? Knowledge of Lean SixSigma methodologies would be a plus.