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Sr. Microbiologist

Pfizer


Location:
Kalamazoo, MI
Date:
12/16/2017
2017-12-162018-01-23
Pfizer
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Job Details

**Role Summary**



Uses 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 facilities/processes and for new facilities/processes. 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 R&D. 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 RESPONSIBILITIES**







Candidate 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



+ 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 as subject matter expert 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.



+ Independently implementing new environmental monitoring programs or changes to existing environmental monitoring programs



+ Independently determining environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities.



+ Independently writing and executing environmental monitoring PQ protocols for aseptic facility modifications and new facilities and oversight of technical staff conducting executing the protocols.







**QUALIFICATIONS**







BS in Microbiology, Bacteriology, or related biological science is required and 5-7 years experience in aseptic pharmaceutical production environment or MS/PhD and 3 years experience. Understanding of aseptic processing and aseptic laboratory techniques and aseptic proceesing regulatory guidelines. Previous experience in environmental monitoring / microbiological process control in an industrial or aseptic pharmaceutical production environment. Good oral, written and interpersonal communication skills are required. Candidate should possess computer skills in multiple programs such as data entry, word processing, and spreadsheets. A high level of attention to detail is also required. The successful candidate will also demonstrate the ability to organize time independently and prioritize their workload in order to meet objectives in a flexible, team-oriented environment.







Job duties involve occasional lifting (less than 35 lbs), reaching, and sitting while working at computer terminal. Successful candidate will be required to complete aseptic gowning certification (Grade A) in order to work in aseptic manufacturing areas.







**EEO & Employment Eligibility**



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Last Date to Apply for Job: 12/29/17**



Eligible for Relocation Package







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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