MQ&SA Senior Scientist Full-time

Senior Scientist

The Senior Scientist is responsible for principle duties: R&D – Provide input for the following for increasing complexity projects: Design for cleanability Design for decontamination Design for sterilizability Drive selection of sterilization modality, validation approaches and validation of the sterilization process. Generate sterilization product adoptions. Support the regulatory approval of sterile and non-sterile new products, including internal research & development products, new acquisitions, and strategic partnerships. Support the implementation of new innovations in the areas of contamination control, terminal sterilization, and reprocessing, to include such activities as participating in development of new products. Plan – Provide input into the selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers). Source – Provide sterility assurance and contamination control support for due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J. Provide sterility assurance and contamination control for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured. Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint. Provide input for the design of critical water and air systems and the design of controlled environments and cleanliness control strategies. Provide sterility assurance and contamination control support for supplier audits. Make – Provide sterility assurance and contamination control support to strategic MAKE initiatives. Provide input into process risk assessments related to product cleanliness and sterility assurance. Lead non-conformance/CAPA pertaining to product cleanliness and sterility assurance. NC/CAPA Work with internal and external laboratories to support sterility assurance testing requirements. Assure implementation of laboratory testing requirements for cleanliness and sterility assurance. Provide support to internal and external audits. Deliver – 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 – Provide site input to the J&J representatives of industry and standards associations (e.g., AAMI, ISO, AORN), influencing regulations and standards. Internal Influencing – Participate on the J&J Sterility Assurance Councils.