Job Function: R&D Product Development
Job Sub Function: R&D Process Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America
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.
Required Skills:Preferred Skills:Agile Decision Making, AI Judgement Integration, Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Mentorship, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, Research and Development, SAP Product Lifecycle Management, Tactical Planning, Technical Credibility, Technical Research, Technical Writing
The anticipated base pay range for this position is :$140,000.00 - $241,500.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
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
