Sterility Assurance Engineer

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
• 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
• 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
• 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
• 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: Bachelor of Science in a Life Science or Engineering with specific coursework in Microbiology a plus. 3+ years experience & demonstrated proficiency in reusable medical device processing and sterilization.
• Sufficient experience & training in device processing of reusable medical devices to include moist heat and VHP sterilization modalities a must, proficient in microbiology laboratory procedures to independently resolve cleaning and/or sterilization process issues & coordinate appropriate testing and experience with radiation and ethylene oxide sterilization experience a plus.
• Guidance from a more experienced sterilization scientist on unusual or especially difficult problems is necessary Demonstrated ability to work effectively in a team environment, Make effective management level presentations & write formal reports Training & experience in Good Manufacturing Practices & ISO are also required Preferred: Advanced Degree New product development experience Course work or lab work in Microbiology Other: Ability to travel up to 20% occasional domestic and international 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 .
• Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.
• We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
• Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.
• If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
• Required Skills: Preferred Skills: Analytical Reasoning, Biochemical Engineering, Biological Sciences, Chemical Engineering, Chemistry, Collaboration, Data Synthesis, Execution Focus, Innovation, Manufacturing Processes, Numerically Savvy, Process Chemistry, Process Improvements, Research and Development, Sample Testing, SAP Product Lifecycle Management, Technical Research, Technologically Savvy The anticipated base pay range for this position is : $76,000.00 - $121,900.00 Additional Description for Pay Transparency: This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year
• for employees who reside in the State of Colorado –48 hours per calendar year
• for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits