Scientist II Microbiologist - EM Focus

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a microbiologist position (environmental monitoring focus) working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Qualifications Bachelor’s degree required; concentration in a scientific or applied discipline strongly preferred A minimum of one year of experience in pharmaceutical microbiology related position required specific to environmental monitoring (EM) Required Skills and Experience Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring Responsibilities ENVIRONMENTAL MONITORING Proficiency in the pharmaceutical microbiology laboratory workflow for EM collection and testing, reporting and trending Sampling EM rooms, surface and air Collection and testing water samples Weekly water trends- visually to be able to report back to the source area Equipment responsibilities with metrology oversight, automation, etc MODA USE Assist with writing annual reports Assist with writing trend reports Able to interpret adverse vs desirable data Mold investigations and studies PSIM work Biological indicator analysis and certification Disinfection studies where appropriate Critical thinking with data MICROBIOLOGICAL PRODUCT ANALYSIS Analyze samples and compile meaningful data Perform Investigations and prepare/respond to CAPA Review Test Procedures/Standard Operating Procedures Ad Hoc work Rotational on-call assignments for responding to alarms MICROBIOLOGICAL ACTIVITIES Include (but not limited to): Receive, verify & Log in samples Return templates and shipping paperwork when and where appropriate Prepare and ship materials offsite for ID/testing (when applicable) Stock culture management and quality control of same Biological indicator management Bioburden testing Water sampling Microbiological media management and quality control of same Sterilization activities CALIBRATIONS: Execute “Before-Use” calibrations prior to performing testing Review calibration data within the ELN Prepare and submit equipment for calibrations (offsite or onsite) Complete calibration/PM paperwork GMP ACTIVITIES: Prepare GMP documentation as requested by management Perform laboratory sanitizations and ensure cleanliness of laboratory workspace Perform equipment sanitizations (incubators / hoods / refrigerators) Purchase supplies (GMP) Prepare and send documents to Records Center INVESTIGATIONS: Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)] Inform management of non-conforming events AUDITS: Participate in audits (Regulatory, In-house, Corporate) Participate in self-inspections and safety inspections Retrieve data when requested by Microbiology management TRAINING: Complete assigned training when required Ensure training is complete prior to performing tasks This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination. About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.