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Ethicon, Inc. Principal Engineer Stability in Raritan, New Jersey

Employer: Ethicon, Inc.Job Title: Principal Engineer StabilityJob Code: A011.5116Job Location: Raritan, NJJob Type: Full-Time Rate of Pay: $182,000 - $211,200Job Duties: Lead engineering and project management activities for medical device stability laboratory programs. Oversee and optimize stability chambers maintenance, calibration, and validation activities. Develop optimized, innovative stability analytic techniques for medical devices according to established procedures, ensuring quality standards are met. Track, monitor, and drive optimization projects. Implement protocols, reports, and other stability documents in LIMS. Act as a Stability Process Manager using 6 sigma approaches for all aspects of new stability equipment required in GMP stability laboratory, including but not limited to procurement, qualifications/validations, and all associated quality documents. Update and release of stability documents. Conduct all phases of standard Medical Device IQ/OQ/PQ and TMV activities for environmental chamber, photo chamber, packaging and physical testing equipment. Provide guidance to staff members regarding annual stability protocol design approaches, test evaluations and data analyses, and trends for combination drugs and devices. Conduct stability testing design programs using state-of-the-art processes, technologies, and data analysis tools. Develop research stress testing/forced degradation proposals to meet exploratory objectives in product testing and analysis, to provide a sound basis for developing and evaluating new or improved products, processes, and analytical or physical testing techniques. Support stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards. Implement initiatives to improve efficiency, cycle times, and productivity, including creating and improving document templates. Acquire data from diverse data lakes, data clusters, cloud data services, and other sources. Monitor current scientific developments and new techniques to apply theories and concepts to improve stability capabilities and stability compliance. Present business-related issues or opportunities to next management level.Requirements: Employer will accept a Bachelor's degree in Chemistry, Biology, Mechanical Engineering, Packaging Engineering or related field followed by 7 years of progressive, post-baccalaureate experience in the job offered or in a Principal Engineer Stability-related occupation..CONTACT: To apply, please send resume to jkim6240@its.jnj.com. Please refer to Job #A011.5116.

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