Sr. Principal Engineer, Radiation Sterilization

Key Responsibilities

• Collaborate with R&D, Q&C, and Regulatory Affairs on product and packaging development, clinical evaluation, and product/process validation.
• Drive generation of innovative test methods and practices.
• Engage with JJMQSA peers to deliver sterilization solutions.
• Work directly with project leaders to define product and sterilization needs and validate those needs, as required.
• Support operating company affiliates in maintaining regulatory readiness and conducting due diligence for potential acquisitions.
• Support selection and assessment of new sterilization operations, including contract sterilization providers and laboratories.
• Provide due-diligence and technical SME support for integration into the J&J consolidated cycle strategy, as needed.
• Act as technical SME supporting procurement activities for externally manufactured sterilized products or components.
• Provide direct support to the extended team in IQ, OQ, and PQ of sterilization equipment.
• Support operating companies with gap analysis, root-cause investigation of routine process failures, training, consultation, and regulatory inspection readiness.
• Provide support, when required, for Ethylene Oxide (EO) sterilization of products or components at internal or external manufacturing sites.
• Ensure sterilization and processing compliance with EO industry standards and regulatory requirements, including safety and security.
• Actively network with internal and external scientific, technical, and regulatory communities to advance sterilization knowledge.
• Represent the corporation at industry and standards associations, including ISO, AAMI, and ASTM, to influence regulations and standards.
• Develop and deploy programs to build, train, and maintain competencies for new hires and current/next-generation Sterility Assurance talent.
• Support maintenance and implementation of radiation sterilization enterprise standards.

Qualifications

• B.A./B.S. in life science, engineering, or a related scientific/technical field is required; biology, microbiology, physics, or similar disciplines preferred.
• Minimum of 10 years of direct experience with radiation sterilization equipment and processing.
• Recognized as a subject-matter authority with significant achievements in the area of expertise.
• Strong skills with technical tools, such as Process Excellence or similar tools.
• Strong influencing skills inside and outside the work group.
• Knowledge of theory and practical applications of experimental techniques.
• Ability to conduct diverse scientific projects in an organized and productive manner.
• Ability to develop and deliver training programs related to Sterility Assurance.
• Ability to write clear, focused, and intellectually sound reports and deliver presentations.
• External publication and/or presentation experience, high-level knowledge of industry standards, and experience interacting with regulatory authorities.
• Proven experience leveraging Artificial Intelligence (AI) technologies to enhance personal productivity and/or department performance is preferred.

This is a hybrid role available in all states within requisition's country. Remote work options may be considered on a case-by-case basis and if approved by the Company.