About the Company:
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Microbiologist to be located in West Chester, PA.
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and Instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
The Microbiologist will be responsible for the implementation and support of Environmental Monitoring (EM) and contamination control at our Manufacturing site in compliance with US FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001.
Position Duties & Responsibilities: The Microbiologist will provide biological testing oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness at the manufacturing facilities.
Work closely with the Manufacturing and Quality groups to establish and maintain procedures, tools and methodologies related to the Environmental Monitoring program. Maintain knowledge of FDA & ISO EM guidelines, as applicable. Conduct technical assessments of contract laboratories. Provide guidance and training to personnel to ensure Environmental Monitoring program requirements are met.
Provide input on design of manufacturing processes, controlled environments and finishing, including cleaning, to ensure their efficacy, for obtaining clean and safe products. Provide input on design of systems to generate processed water. Support validation of processed Water, controlled environment and finishing process. Provide guidance to plant personnel, as required, ensuring good manufacturing and good documentation practice. Know and follow all laws and policies that apply to the position, and maintain the highest levels of professionalism, ethics and compliance at all times. Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Other duties/responsibilities as assigned by manager.
Qualification and Experience:
Qualifications; To meet requirements, a Bachelor's degree (focus on Microbiology, Biological Science, or Engineering is preferred) and 3 years’ of microbiological experience; or an advanced degree (M.S., PhD) and 1 year of microbiological experience. Industry experience in medical device and/or pharmaceutical is highly preferred. Experience working in a GMP-regulated environment is required. Experience with sterilization processes, microbiological testing, and water testing is strongly preferred. Environmental monitoring, testing, and investigational experience is required.
Strong knowledge in government regulations and industry guidelines for environmental monitoring (e.g. ISO/EN/AAMI) and knowledge/familiarity in microbiological control of medical devices is preferred.
Taking a highly collaborative approach with ability to work independently and in a highly professional manner is required. Excellent communication/organization/tim
How to Apply:
Apply online through company website or LinkedIn
Date Advertisement Posted - 19th December 2015
Job Number - 1851151202
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