We believe health is everything at Johnson & Johnson.
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.
This role will serve as a global technical leader driving strategy, implementation, and deployment of gaseous sterilization solutions across the end-to-end business.
The candidate will consult on critical methods and research to achieve operational, functional, and/or business targets with measurable impact on department results.
Responsibilities
1. Collaboration with various groups (R&D, Q&C, and Regulatory Affairs) on product and packaging development, clinical evaluation, and product/process validation.
2. Drive generation of new innovative test methods and practices.
3. Engage with the horizontal and vertical JJSA peers to deliver sterilization solutions.
4. Work directly with the project leaders to define product and sterilization needs.
Action Plan
1. Support operating company affiliates in maintaining regulatory readiness and due diligence of potential acquisitions.
2. Support the selection and assessment of the new sterilization operations (to include contract sterilization & laboratories).
Sources
1. Provide technical SME support for integration into the J&J consolidated cycle strategy.
2. Act as a technical SME in support for procurement activities for sterilized products or components that are externally manufactured.
Production
1. Provide direct support to the extended team in the IQ, OQ and PQ of sterilization equipment.
2. Provide support for the Ethylene Oxide (EO) sterilization of products or components at internal or external manufacturing sites.
Delivery
1. Ensure sterilization and processing compliance with Ethylene Oxide (EO) industry standards and regulatory requirements including safety and security.
External Influencing
1. Actively network with the internal and external scientific, technical and regulatory community to advance sterilization knowledge.
2. Represent the corporation at industry and standards associations (e.g., ISO, AAMI, ASTM, etc.) influencing regulations and standards.
Internal Influence
1. Develop and deploy programs to develop/train/maintain competencies across the corporation for new hires, as well as current/next generation sterility assurance talent.
Bachelor's degree in life science, engineering or related field required. Minimum ten years direct experience with gaseous sterilization equipment and processing. Recognized subject matter authority with significant achievements in area(s) of expertise.