Senior Scientist, Gas and Heat Sterilization
Senior Scientist, Gas and Heat Sterilization
Johnson & Johnson
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a Senior Scientist, Gas and Heat Sterilization. This position can be based out of Raritan, NJ or remote and proximity to a major airport is preferred.
Our Story is this. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people, ultimately touching the lives of over a billion people every day, throughout the world. We flourish based on a diverse company culture, and celebrate the uniqueness of our employees and a serious commitment to inclusion. J&J is proud to be an equal opportunity employer.
The Senior Scientist, Gas and Heath Sterilization role will:
- Serve as a global technical leader in the areas of gas & heat processing with responsibility to support all J&J locations worldwide Supports compliance and risk based evaluations and provides in-depth technical support for new and existing gas & heat activities.
- Supports the groups and company's strategic and tactical directions through the application of technical knowledge and expertise in gas & heat processing.
- Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge including representing the corporation at industry and standards associations (e.g., ISO, AAMI, ASTM, EOSA), influencing regulations and standards that allows for the opportunity to develop next generation of J&J sterility assurance employees
Additional Responsibilities include
- Collaboration with various groups (R&D, Q&C, and Regulatory Affairs) on product and packaging development (maximum acceptable dose determination), clinical evaluation, product/process validation.
- Support the development of new innovative test methods and practices in the areas of gas & heat processing.
- Work directly with the horizontal and vertical JJSA peers to find break-through technologies in gas & heat processing.
- Work directly with the project leaders to define product and sterilization needs for gas & heat processed products including the validation of those needs (as needed)
- Support operating company affiliates in maintaining regulatory readiness and due diligence of potential acquisitions.
- Support the selection and assessment of new sterilization operations (to include contract sterilization & laboratories) as it relates to E2E sterility assurance focused on gas & heat processing
- Support, as needed, due diligence for gas & heat sterilized products, and provide technical SME support for integration into J&J
- Act as a technical SME in support for procurement activities that relate to gas & heat sterilized products or components that are externally manufactured.
- Provide direct support to the extended sterility assurance team in the IQ, OQ and PQ of equipment and controlled manufacturing environments (CME's) used for gas & heat processed or treated healthcare and consumer products.
- 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 gas & heat processing of products or components at internal or external manufacturing sites.
External and Internal Influencing
- Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
- Execute programs to develop/train/maintain gas & heat processing 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 the enterprise Standards associated with gas & heat processing.
Serve as a member on the Sterilization Council (as required).
A minimum of a Bachelor's degree in Sciences, Engineering, Physics, or other related science is required.
- A minimum of 8 years of working experience in related field is required.
- Working knowledge of one or more of the following sterilization modalities: Steam/Moist Heat, Ethylene Oxide, Dry Heat, Hydrogen Peroxide, Nitrogen Dioxide or Other related modalities is preferred.
- Hands on experience in the operation of gas & heat sterilizers and/or previous experience as an operator / supervisor / technical/quality of and an industrial process is required.
- Knowledge in quality system activities and QA compliance for change control, calibration, preventative maintenance, data analysis, and documentation is required
- The individual will be a self-starting results oriented individual with the ability to work independently while also being a productive contributing team player.
- Excellent written and verbal communication skills.
- Ability to work in a matrix environment, with senior level management
- Ability to influence and present sensitive information to all levels of the organization is required.
- Effective time management skills to allow for multi-tasking of responsibilities.
- This position will require up to 25% travel domestic and international.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
United States-New Jersey-Raritan
Johnson & Johnson International (6078)