Johnson & Johnson Careers
Senior Manager, Sterility Assurance
Requisition ID: 0959181221
Ethicon, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Senior Manager, Sterility Assurance to be located in Somerville, NJ; Raritan, NJ; Horsham, PA; Somerville, NJ; or any NA Ethicon Manufacturing Locations.
Ethicon has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
The Senior Manager, Sterility Assurance position is responsible for E2E implementation of sterility assurance policies and strategies for Ethicon and will assure that Ethicon programs are aligned with the overall Global Surgery and J&J Sterility Assurance programs.
The Senior Manager, Sterility Assurance will be accountable to all Ethicon operating companies and development organizations, design centers and manufacturing sites (to include both internal and external sites). He/she will serve as the global technical leader in the areas of aseptic processing, sterilization, reprocessing and microbiology with responsibility for all Ethicon locations worldwide. This individual will be responsible for defining company policy and developing company strategies with respect to cleanliness, aseptic processing, sterilization, clean rooms, water/air systems and related areas.
This Senior Manager will oversee the following technical areas: aseptic processing, sterilization validation (for EO, gamma, electron beam, moist heat, and dry heat processes), reprocessing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, BET), environmental control and monitoring, water and air systems validation, sterility assurance support to new product development and launch, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories, inspection and submission support.
This role will also be responsible for activities such as, but not limited to, the following:
- R&D –
- Support R&D in the selection of modalities, cycle development and process validations
- Support the development of new innovations in the area of contamination control and terminal sterilization, to include such activities as interaction with internal and external experts, participating in development of new products
- Work directly with the Ethicon R&D teams and Technical Vertical JJSA Leaders to find break-through technologies to enable future growth and innovations
- Selection of the aseptic processing and/or sterilization process for new products, and the sites for execution
- Work directly with the packaging leaders to define package needs for terminal sterilization and/or aseptic processing, and validation of the primary packaging
- Life Cycle Management of aseptic processing and/or sterilization process for product portfolio within Ethicon
- Plan –
- Mandatory involvement in selection of new manufacturing operations (to include aseptic processing manufacturing sites, contract sterilization, contract laboratories, and third-party manufacturers)
- Provide guidance about the manufacturing site regarding the control and monitoring of the environment
- Source –
- Mandatory involvement in due diligence for sterile or microbiologically controlled manufactured products, and provide technical SME support
- Provide technical SME support for procurement activities that relate to sterile or microbiologically controlled products that are externally manufactured
- Identifies the microbiological controls needed for the components or raw materials coming into the manufacturing sites
- Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological and terminal sterilization point of view
- Input for the design of critical water & air systems and the design of controlled environments and cleanliness control strategies
- Make –
- Maintain close involvement/alignment with the Product Management and Engineering organizations to develop technical competencies for future products
- Maintain close involvement/alignment with the Make Organization manufacturing sites, with a pro-active scan from a sterility risks standpoint and drive remediation, if required
- Establish long-range sterility assurance strategies for Ethicon products
- Maintain close involvement/alignment with the Sterilization Execution organization to support the long term Supply Chain sterilization strategy to enable future network growth focused on reliability, capability while reducing liability and deliver an integrated BCP to reduce supply chain risks
- Strategy for sterility assurance organization to support the release of sterile label products, and addressing any issues that might arise during the execution of the sterilization processes
- Deliver –
- Advise on ongoing initiatives regards the validation and improvement of primary sterile packaging systems that meet the needs of the sterile or microbiologically controlled product from manufacture, through storage and distribution to the patient and/or consumer
- Advise on how best to maintain sterility
- External Influencing –
- Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge
- As required, represent the corporation at industry and standards associations (e.g., AAMI, ISO), influencing regulations and standards
- Internal Influencing –
- Represent Ethicon sterility assurance on the Technical Operations and Make organizations governing council
- Represent Sterility Assurance on Ethicon product management boards
- A Bachelor’s degree in Microbiology, Biology, Engineering or related discipline is required; an advanced degree in Pharmacy, MS or PhD is preferred.
- A minimum of 10 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required
- A minimum of 5 years of direct people management experience is required
- Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls is required
- Demonstrated competency in terminal sterilization and microbiological contamination is required
- Experience in a minimum of 2 modes of industrial terminal sterilization (e.g., EO, gamma, electron beam, moist heat, dry heat) is required
- Experience interacting with Regulatory Authorities is preferred
- Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred
- Proven track record on trouble shooting microbiological, aseptic processing and/or sterilization process non-conformances and out of specification test results, and providing resolution to issues via robust CAPA is required
- High level knowledge of standards including EU and ISO is required
- Capable of representing the corporation at industry and standards associations, influencing regulations and standards is preferred
- Ability to communicate both up and down the business ladder within franchise or technical competency area is required
- Ability to work in a collaborative/teamwork environment is required
- Independent organizational and time management skills, as well as a team player mindset with a customer focus are required
- This position will be located in Somerville, NJ; Raritan, NJ; Horsham, PA; Somerville, NJ; or any NA Ethicon Manufacturing Locations, and may require up to 50% domestic and international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States, United States-New Jersey-Raritan, United States-Pennsylvania-Horsham, United States-New Jersey-Somerville
Ethicon Endo Surgery Inc (6041)