Sterility Assurance Supervisor

The Sterility Assurance Supervisor is responsible for end-to-end implementation of contamination control and sterility assurance policies for the manufacturing of commercial products within Global Orthopedics, located in Warsaw, IN. The Sterility Assurance Supervisor will serve as the Business Unit/Franchise technical leader in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology. He/she manages team to support product manufacturing activities. This individual will be responsible for activities such as, but not limited to, the following: •R&D o Provide technical support in the selection, investigation and validation of aseptic manufacturing and sterilization methodologies o Support due diligence on contamination control and sterility assurance for acquisitions and new product licensing o Provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally •Plan o Provide support in the development and selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers) •Source o Provide support in Business Unit/Franchise due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J o Provide technical SME support for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured o Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint o Provide input for the design of critical water and air systems and the design of controlled environments and cleanliness control strategies o Provide technical SME support for sterility assurance and contamination control in supplier audits. •Make o ensure the implementation of contamination control and sterility assurance policies at defined manufacturing facilities o Ensure process changes meet contamination control and sterility assurance requirements o Lead the investigation, gap analysis and develop the corrective action plan for microbiological or contamination control CAPAs and non-conformances, including root cause identification and corrective action implantation within agreed timelines o Supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers. o Provide technical support during onsite inspections o Work with internal and external laboratories to support sterility assurance testing requirements. Assure implementation of laboratory testing requirements for cleanliness and sterility assurance. o Work with the local Sterilization Execution organization to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilization processes •Deliver o Support the ongoing initiatives regarding the validation and improvement of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer •External Influencing o Monitors best practices in sterility assurance and contamination control by interacting with JJSA leadership. •Internal Influencing o Interacts with business leaders to ensure objectives and project prioritization meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities. o Participate on the J&J Sterility Assurance Councils The Sterility Assurance Supervisor technical areas overseen include: aseptic processing, cleaning and disinfection requirements, 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, endotoxin monitoring), environmental control and monitoring, water and air systems validation, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories. Inspection and submission support and Health based risk assessment. The Sterility Assurance Supervisor will also be responsible to ensure the development of their team to include career development, work-life balance etc. Qualifications • A minimum of a Master’s degree is required, with Microbiology, Biology, Engineering or related discipline is preferred, an advanced degree is desirable. • A minimum of 6 years of related experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required. • Deep Understanding in using computer software such as Excel, Word and PowerPoint, and analytical software is required. • Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility • Demonstrated capability to lead and train staff with hands on management experience • Demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat) is required. Experience with gas plasma or VHP sterilization methods is preferred. • Proven track record on troubleshooting process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process • Experience in interacting with Regulatory Authorities is preferred • Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred • Strong knowledge of standards and regulations related to sterilization, including EU, USA and ISO is required • Strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc. • Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is required • Demonstrated ability to work in a collaborative/teamwork environment is required • Independent organizational and time management skills is required • This role may require up to 10% domestic and/ or 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. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-Indiana-Warsaw-700 Orthopaedic Drive Organization Medical Device Business Services, Inc (6029) Job Function R&D Requisition ID 2206060057W