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

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The Sterility Assurance Team at Johnson & Johnson is recruiting for a Senior Principal Engineer, Gaseous Sterilization. This preferred location for this role is in Raritan, NJ, with considerations given to alternate J& J sites in the US or EMEA and any exceptions to support remotely will be at the discretion of the business.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• US - Requisition Number: R-007438

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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/.

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. Masters knowledge and skills of gaseous sterilization methods, and will serve as a valuable resource to peers. The candidate will use scientific skills for compliance and risk-based evaluations and provides in-depth technical support for sterilized products including process characterization, process development and validation and will support the team and company’s directions through the application of this technical knowledge and expertise. The candidate will manage major complex projects of strategic importance, involving cross-functional teams and liaison with contractors and support the validation and implementation of sterilization processes.

Responsibilities Include:

R& D

• Collaboration with various groups (R& D, Q& C, and Regulatory Affairs) on product and packaging development, clinical evaluation, and product/process validation
• Drive generation of new innovative test methods and practices.
• Engage with the horizontal and vertical JJSA peers to deliver sterilization solutions.
• Work directly with the project leaders to define product and sterilization needs the validation of those needs (as needed)

PLAN

• Support operating company affiliates in maintaining regulatory readiness and due diligence of potential acquisitions.
• Support the selection and assessment of the new sterilization operations (to include contract sterilization & laboratories)

SOURCE

• Support, as needed, due diligence and provide technical SME support for integration into the J& J consolidated cycle strategy.
• Act as a technical SME in support for procurement activities for sterilized products or components that are externally manufactured.

MAKE

• Provide direct support to the extended team in the IQ, OQ and PQ of sterilization equipment.
• Provide support, when required, to operating companies in gap analysis and root cause investigation of routine process failures, training and consultation as well as in assessing and improving regulatory inspection readiness.
• Provide support, when required, for the Ethylene Oxide (EO) sterilization of products or components at internal or external manufacturing sites.

DELIVER

• Ensure sterilization and processing compliance with Ethylene Oxide (EO) industry standards and regulatory requirements including safety and security.

EXTERNAL INFLUENCING

• Actively network with the internal and external scientific, technical and regulatory community to advance sterilization knowledge
• Represent the corporation at industry and standards associations (e.g., ISO, AAMI, ASTM, etc.) influencing regulations and standards

INTERNAL INFLUENCING

• Develop and deploy programs to develop/train/maintain competencies across the corporation for new hires, as well as current/next generation sterility assurance talent to ensure understanding and compliance with Corporate and regulatory standards.
• Support the maintenance and implementation of gaseous sterilization enterprise Standards

Qualifications / Requirements:

• B.A./B.S. in life science, engineering or related scientific/technical field required (e.g. biology, microbiology, physics, etc. preferred)
• A minimum of ten years direct experience with gaseous sterilization equipment and processing.
• Recognized as subject matter authority and has made significant achievements in area(s) of expertise.
• Strong skills in technical tools (e.g., Process Excellence or similar tools).
• Demonstrates strong influencing skills inside and outside of work group.
• Knowledgeable of theory, and practical applications of experimental techniques.
• Can conduct diverse scientific projects in an organized and productive manner.
• Develops and deliver training programs relating to Sterility Assurance.
• Able to write reports and deliver presentations, which are clear, focused, and intellectually sound
• Author and/or present external publications and exhibit high level knowledge of industry standards and experience in interacting with Regulatory Authorities.