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Staff Engineer, Global Product Stability
Requisition ID: 0409180122
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Engineer, Global Product Stability, to be located in Somerville, New Jersey.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.
The Staff Engineer will provide leadership/representation on multidisciplinary project teams as a Global Product Stability Group authority and a stability study director, and will understand stability protocols and how they are interpreted via LIMS.
You will deploy and sustain stability best practices toward successful development and manufacture of medical devices and combination products.
You will author stability program procedures, work instructions, and templates, and ensure documentation in support of expiry dating is in alignment with company, industry and regulatory guidelines.
You will partner with multi-functional partners in Business Unit R&D, Packaging, Operations, Regulatory Affairs, and Quality to proactively identify and correct any product or process-related issues and ensure the Stability LIMS system aligns with any corrections incorporated into process/procedures.
You will interact with internal J&J stability groups and external collaborators to increase the stability capabilities of the Ethicon group, and provide instructor-led training for approved stability documents, processes and LIMS functionality.
The Staff Engineer will be expected to mentor team members with more limited experience in stability regulations and practices, and adopt a team-oriented environment conducive to change, appropriate risk-taking, and flexibility.
You will also make configuration updates to the LIMS system and document the updates via the Ethicon Change Control process.
-A minimum of a Bachelor’s degree in science, engineering, or related field is required
-At least five years of experience in an FDA or highly regulated industry, and an in-depth knowledge of stability operations and industry best practices is required
-Experience with Computer System Validation is required
-Experience with NPD Testing, Test Method Validation/Transfer and Internal Auditing are preferred
-A working knowledge of medical device regulations, standards, and guidance documents is strongly preferred
Knowledge of Stability Information Management systems, systems administration and configuration (e.g. LIMS) and experience working in QC/QA laboratory and/or manufacturing cGXP environment are required
-Certification as LIMS or Empower Administrator is highly desirable
-Candidates must possess a consistent track record of successfully leading projects and successfully working with multi-functional teams
-The ability to cultivate a productive team-oriented environment, handle multiple assignments, and display flexibility in response to an environment with shifting priorities is strongly desired
-Well-developed problem-solving skills, and excellent communication skills are required for long term success in this role
This position is based in Somerville (NJ) and may require up to 25% travel.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United States-New Jersey-Somerville
Ethicon Inc. (6045)
R&D Engineering (R&D)