HireDiversity

Raritan, NJ, US

DIRECTOR GASEOUS STERILIZATION (EO/Moist Heat/Dry Heat)-6967121009

Description

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

The Director Terminal Sterilization Processing leads and directs sterile processing operations and Corporate support responsibilities of Sterilization Assurance for gaseous and heat sterilization processes (Ethylene Oxide / Moist Heat / Dry Heat). He/she influences the company's strategic and tactical directions and financial results through the application of technical knowledge and expertise in terminal sterilization processing for healthcare (medical device and pharmaceuticals) and consumer products.

The candidate will be responsible for directing the activities of the Sterilization Assurance Ethylene Oxide and moist/dry heat sterilization and engineering groups. Responsibilities of these groups will include day-to-day activities related to the processing of customer samples from across J&J operating companies. This will include collaboration with various groups (R&D, Q&C, and Regulatory Affairs) on product and packaging development, clinical evaluation, cycle development/validation, parametric release and design/development of process challenge devices. Other duties include customer consultation on development and implementation of sterilization strategies, optimization of current sterilization processes/equipment utilization and the deployment of sterilization best practices. This individual will also be responsible for driving the development and implementation of new technologies, maintaining Enterprise Standards for these sterilization modalities and establishing programs to develop/train/maintain sterilization engineering competencies across the corporation for new hires, as well as current/next generation sterilization talent to ensure understanding and compliance with Corporate and regulatory standards. Supports operating company affiliates in maintaining regulatory readiness and due diligence of potential acquisitions. Serve as the co-lead for the Sterilization Leadership Team with sector representatives.

Qualifications


Individual must have a minimum of a Bachelors degree in Engineering, Microbiology, Biology or equivalent discipline with a minimum 15 years related experience required. An advanced degree would be preferred. The candidate will have hands on operational experience in sterilization operations, R&D, or closely related field. Strong industry expertise in gaseous or heat (EO/Moist Heat/Dry Heat) sterilization is highly preferred. High level and detailed knowledge of AAMI/ISO standards related to these modalities, and experience in interacting with Regulatory Authorities required. A track record of authoring multiple peer reviewed publications; demonstrated high level skills in Process/Design Excellence, statistical process control, and the ability to provide statistical support in the design of experiments, sampling plans, and hypothesis testing is highly desired. He/she must have an understanding of the sterilization process microbiological lethality as it relates to both product design and sterilization process equipment capabilities and biological indicator D and z-value calculations. Prior experience with designed/ performed process validations to support the demonstration of achieving the desired Sterility Assurance Level is also required. In addition, it is preferred if the individual will have experience in preparing the analysis and justification of sterilizer vessel equivalency and parametric release, calibration of monitoring/controlling equipment, and with impact of the sterilization process on product and packaging functionality. Strong experience performing IQ/OQ/PQ is a requirement. A proven track record on trouble shooting process non-conformances and out of specification test results and providing resolution to issues via robust CAPA required. Experience with conducting audits of in-house and contract sterilization processes would be a plus.

Individual must have demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity. The candidate must be capable of representing the corporation on industry standards association such as AAMI, PDA, etc. This position may require up to 30% domestic and international travel as needed by business. This position will be based in Raritan, NJ.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Organization: Johnson & Johnson International (6078)