Sterility Assurance Engineer

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: R&D Chemical/Biochemical Engineering Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: J&J MedTech is recruiting for a Sterility Assurance Engineer, New Product Development, located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Sterility Assurance Engineer provides expert technical and business leadership to development teams and operations in the area of sterility assurance. This role functions as a subject matter expert in device processing, sterilization, and microbiological quality, and is responsible for evaluating technical and regulatory requirements against business needs to support the development and maintenance of corporate-level policies, procedures, and strategies impacting sterile single-use and reusable products, facilities, and external partners. In the context of New Product Development, the Sterility Assurance Engineer delivers microbiological quality and sterility assurance expertise, ensuring robust support and leadership throughout the product development lifecycle. Responsibilities: Leads cross-functional execution of validation and development protocols, ensuring alignment with project objectives, regulatory requirements, and quality standards; oversees generation, advanced data analysis, and approval of technically rigorous completion reports and supporting documentation. Defines and drives cleaning, sterilization and disinfection strategies in partnership with cross-functional stakeholders, providing technical leadership to support product development, design inputs, and global regulatory submissions. Provides technical and operational leadership for cleaning and sterilization modalities at the Raritan JJSA facility, including oversight of sample processing, laboratory safety compliance, and training programs to ensure consistent and compliant execution. Leads execution and coordination of sample processing and validation activities supporting new product development and process optimization; ensures compliant validation of sterilization and reprocessing methods Manages multiple concurrent projects and programs associated with cleaning and sterilization, driving prioritization, resource alignment, and on-time delivery of technical and service objectives for the Raritan site. Own the development, governance, and continuous improvement of a compliant validation laboratory, ensuring adherence to GMP/ISO requirements through implementation of robust quality systems, documentation control, equipment lifecycle management (qualification, calibration, and maintenance), and sustained validated state of laboratory operations. Translate sterilization and reprocessing requirements into product design inputs, engineering specifications, and development plans to ensure alignment with system-level performance and project milestones. Assist in SPD communication and complaint investigations. Lead development of cleaning validation strategies as part of product design, integrating manual and automated reprocessing considerations into device architecture, including definition of worst-case design conditions (e.g., soil retention features, material interfaces, geometry, and use scenarios). Drive design for cleanability and sterilization as a core engineering requirement, influencing: Material selection and compatibility; Surface finishes and coatings; Device architecture and accessibility; Fluid pathways and interfaces impacting reprocessing effectiveness. Evaluate and select cleaning agents and chemistries from an engineering compatibility perspective, ensuring: Material durability and chemical resistance, System interaction (e.g., seals, adhesives, polymers) and Long-term product performance and reliability. Integrate automated cleaning system requirements into product and accessory design, ensuring compatibility with industry-standard platforms (e.g., Getinge, Steris, Belimed, Steelco) and user environments. Assess product design robustness across real-world use and reprocessing conditions, including variability in healthcare settings, user interaction, and environmental constraints. Develop and author engineering design documentation supporting reprocessing and sterilization, including: Design inputs/outputs, Risk assessments (e.g., reprocessing-related failure modes) and Verification and validation strategies aligned with applicable standards. Provide microbiological and contamination control design expertise, ensuring device features minimize bioburden retention and support effective sterilization and disinfection. Define sterilization strategies as part of product design and development that include sterilization modality selection and compatibility (EO, radiation, etc.), Test method selection and engineering justification and Manufacturing and packaging considerations impacting sterility assurance. Lead engineering investigations into sterilization and reprocessing failures, performing root cause analysis linked to product design, materials, or process interactions and driving sustainable design solutions. Coordinate cross-functional engineering resources (R&D, manufacturing, suppliers) to support design integration of sterilization and cleaning requirements throughout development. Lead and manage design-centric projects and initiatives, prioritizing high-impact programs involving complex device architectures and reprocessing challenges. Evaluate and qualify external partners and suppliers from a technical and engineering capability standpoint, ensuring alignment with product design and sterilization requirements. Assess and refine sterilization and reprocessing processes with direct linkage to product design performance and system interfaces. Establish engineering direction for sterilization and cleaning validation strategies, ensuring alignment with product design intent, risk profile, and user requirements. Drive optimization of sterilization and reprocessing specifications through engineering innovation, balancing performance, cost, manufacturability, and user usability. Communicate technical risks, design considerations, and engineering trade-offs related to sterilization and cleaning to cross-functional leadership. Contribute to continuous improvement of design methodologies, tools, and engineering best practices related to sterilization and cleaning of medical devices. Ensure engineering compliance with applicable regulatory and quality system requirements, embedding these constraints into design controls and development processes Qualifications Required: Bache