Principal Engineer - Sterilization R&D - (Job Number: 0802953)

Principal Engineer - Sterilization R&D - (Job Number: 0802953) DescriptionEthicon, Inc., a member of Johnson && Johnson's Family of Companies, is recruiting for a Principal Engineer - Sterilization R&&D, located in Somerville, NJ. ETHICON develops and markets products within three divisions: ETHICON Products for wound closure and tissue repair; Johnson && Johnson Wound Management with biosurgical technologies to manage intra-operative bleeding and postoperative leaking, as well as advanced wound care products; and ETHICON Women's Health && Urology with minimally invasive gynecological and urological solutions in stress urinary incontinence, pelvic floor repair and uterine disorders The Principal Engineer will assure the sterility of medical devices manufactured by Ethicon and/or associated suppliers world-wide. To drive global solutions, innovation and technology solutions related to sterile product Functions as the technical expert in sterilization and microbiological control issues, evaluating technical and regulatory requirements against business needs to develop innovative and cost effective corporate level policies, procedures and strategies impacting all sterile and reusable products, facilities and contractors. Develop and implement corporate sterilization validation policies and procedures; coordinates and approves all sterilization validation testing. Performs technical assessments of contract sterilization facilities and contract laboratories. Participates on company teams representing sterilizations sciences functional areas. Advises QA, RA and Product Inquiry on specific sterilization and microbiology issues. Directs staff in managing projects involving technical personnel reporting on temporary assignment to facilitate sterilization validations. Leads company teams to accomplish R && D sterilization and microbiological related projects. Acts as a mentor to more junior staff and advises top management on technical matters. Represent sterilization activities during internal and external agency audits BA/BS required. Advanced Technical degree (MS, or PhD) preferred . Minimum 8 years of related medical device sterilization experience is required. Experience with Radiation sterilization (Photon and Electron)and Ethylene Oxide sterilization is required. Working knowledge of Aseptic Processing, Moist Heat, Sterrad and chlorine dioxide sterilization processes a preferred. Knowledge of ISO and cGMP regulations is required. In depth knowledge of FDA and international guidelines is required. Superior project management experience and strong leadership skills are critical. Strong analytical and communications skills are critical. Previous supervisory experience is highly preferred. If you want to explore the many small-company environments behind the big-company impact of the Johnson && Johnson Family of Companies, bid on this position today! Apply Now