Sr. Principal Engineer, Radiation Sterilization

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.

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Job Description:

We are searching for the best talent as Sr. Principal Engineer, Radiation Sterilization.

Purpose:

This role will serve as a global technical leader driving strategy, implementation, and deployment of radiation 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. The candidate will master the knowledge and skills of radiation sterilization methods and serve as a valuable resource to peers. The role uses scientific skills for compliance and risk-based evaluations and provides in-depth technical support for sterilized products, including process characterization, process development, and validation. The candidate will manage major complex projects of strategic importance involving cross-functional teams, contractors, and the validation and implementation of sterilization processes.

Key Responsibilities:

R&D

• 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.

Plan

• 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.

Source

• 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.

Make

• 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.

Deliver

• Ensure sterilization and processing compliance with EO industry standards and regulatory requirements, including safety and security.

External Influencing

• 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.

Internal Influencing

• 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. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

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.

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The anticipated base pay range for this position is :

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For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

About Us

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/.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.