Pfizer Microbiologist in Kalamazoo, Michigan

ROLE SUMMARYUses technical knowledge of Aseptic Processing and Sanitization. Knowledge of applicable technical standards, techniques, principles, theories, concepts and Pfizer processes and industry practices/standards.Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact and recommends and implements appropriate corrective action where necessary. Performs or oversees the performance of qualitative tests or quantitative assays on samples using techniques that vary from use of standard microbiological equipment to highly modern and automated instrumentation.Performs microbiological validation of manufacturing processes and support systems. Evaluates changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards. Conducts and reviews non-conformance investigations related to aseptic manufacturing. Writes microbiological evaluations to support changes to existing facilitiesrocesses and for new facilitiesrocesses. Responsibilities include troubleshooting manufacturing processes.Determines appropriate corrective actions. Applies existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devises and develops new microbiological methods and techniques.Writes SOPs, qualification protocols, technical reports, project plans, etc. Recognizes atypical data, informs supervision of relevant problems, and implements solutions. May also be involved in establishing requirements for the transfer of methodology from RD. May train others in the theory and practice of one or more of these techniques. Focus on leading/overseeing defined processes.Works under general supervision. Refers to policies and practices for guidance and follows established procedures. Operates within established HR policies and basic colleague relations guidelines. Contributes to the completion of specific team objectives and assigned project milestones. Knowledge and demonstration of leadership principles.ROLE RESPONSIBILITIESCandidate will have responsibility for day-to-day execution and functioning of a portion of the environmental monitoring program at the Kalamazoo site. Responsibilities include, but are not limited to:•Independent investigation and documentation of environmental monitoring excursions for the Kalamazoo site•Review and approval of environmental monitoring data and approval of data in LIMS for lot release•Independently conduct Microbiological and Sanitization evaluations on an as needed basis•Entering aseptic manufacturing areas to observe activities and conduct investigations.•Interacting closely with Quality Operations and Drug Product Operations personnel to ensure timeliness, thoroughness, and quality of investigations and deviation resolution•Interfacing with senior management and regulatory agencies to discuss the environmental monitoring program at the site, as well as provide results and trends associated with the program.•Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the environmental monitoring program is compliant with all regulatory requirements•Responsible for writing and executing PQ protocols for aseptic facility modifications and new facilities.•Oversight of technical staffQUALIFICATIONSBS in Microbiology, Bacteriology, or related biological science is required and 3 years experience in aseptic pharmaceutical production environment or MS/PhD and 1 years experience. Understanding of aseptic processing and aseptic laborato