Johnson & Johnson companies are equal opportunity employers.
Microbiologist, Monument Colorado-1655140528
Description
DePuy Synthes is recruiting for a Microbiologist to be located in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
This position is responsible for the implementation and support of Monument facilities Environmental Monitoring (EM) and other biological activities. This position ensures compliance to the applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001. Other applicable ISO standards, AAMI standards/reports, USP and other guidance documents as required. This position provides EM program and biological testing oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness of the Monument facilities manufacturing system. This should be accomplished by working closely with the Manufacturing and Quality groups at Monument.
POSITION DUTIES & RESPONSIBILITIES:
Establish and maintain procedures, tools and methodologies to cover the Monument EM and biological programs. 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. Plant Responsibilities: Working with Management, establish plant specific environmental monitoring requirements. Provide input on design of manufacturing processes, controlled environments and finishing (including passivation, anodization and cleaning) systems to ensure their efficacy from a biological standpoint. Provide input on design of DI water systems. Control biological portion of validation of DI Water, controlled environment and finishing/systems. Provide guidance to plant personnel, as required, ensuring clear, concise and defendable protocols and reports are generated. Compliance Responsibilities: 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.
Qualifications
required. A minimum of 3 years of microbiological experience in the medical device and/or pharmaceutical industry or equivalent education is required. Experience in environmental monitoring program and investigations are required. Knowledgeable in applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001 is preferred. Strong knowledge in government regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred. This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level. The ability to work in a multiple functional groups in an environment that embraces teamwork is required. Experience with GMA sterilization processes, microbiological testing, and water testing is strongly preferred. Proficiency with the Microsoft Office Suite is required. Excellent organizational and time management skills are also required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W: RAPS
J2W: AAPharmS
J2W: AACC
J2W: ASME
J2W: ACS
J2W: Bio2Device
J2W: BioSpace
J2W: BioTech_JC
J2W: MON
J2W: HireDiversity
J2W: ASMCC
J2W: Craigslist_CO
J2W: DU_CIST
J2W: ACRP
J2W: MSL
J2W: Medzilla
J2W: ISM
J2W: PHDs_org
J2W: PMI
J2W: SC_org
Primary Location:North America-United States-Colorado-Monument
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Biology
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Microbiologist, Monument Colorado-1655140528
Description
DePuy Synthes is recruiting for a Microbiologist to be located in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
This position is responsible for the implementation and support of Monument facilities Environmental Monitoring (EM) and other biological activities. This position ensures compliance to the applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001. Other applicable ISO standards, AAMI standards/reports, USP and other guidance documents as required. This position provides EM program and biological testing oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness of the Monument facilities manufacturing system. This should be accomplished by working closely with the Manufacturing and Quality groups at Monument.
POSITION DUTIES & RESPONSIBILITIES:
Establish and maintain procedures, tools and methodologies to cover the Monument EM and biological programs. 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. Plant Responsibilities: Working with Management, establish plant specific environmental monitoring requirements. Provide input on design of manufacturing processes, controlled environments and finishing (including passivation, anodization and cleaning) systems to ensure their efficacy from a biological standpoint. Provide input on design of DI water systems. Control biological portion of validation of DI Water, controlled environment and finishing/systems. Provide guidance to plant personnel, as required, ensuring clear, concise and defendable protocols and reports are generated. Compliance Responsibilities: 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.
Qualifications
required. A minimum of 3 years of microbiological experience in the medical device and/or pharmaceutical industry or equivalent education is required. Experience in environmental monitoring program and investigations are required. Knowledgeable in applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001 is preferred. Strong knowledge in government regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred. This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level. The ability to work in a multiple functional groups in an environment that embraces teamwork is required. Experience with GMA sterilization processes, microbiological testing, and water testing is strongly preferred. Proficiency with the Microsoft Office Suite is required. Excellent organizational and time management skills are also required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W: RAPS
J2W: AAPharmS
J2W: AACC
J2W: ASME
J2W: ACS
J2W: Bio2Device
J2W: BioSpace
J2W: BioTech_JC
J2W: MON
J2W: HireDiversity
J2W: ASMCC
J2W: Craigslist_CO
J2W: DU_CIST
J2W: ACRP
J2W: MSL
J2W: Medzilla
J2W: ISM
J2W: PHDs_org
J2W: PMI
J2W: SC_org
Primary Location:North America-United States-Colorado-Monument
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Biology
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement