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Johnson & Johnson Services, Inc.

Staff Manufacturing Process Engineer

Johnson & Johnson Services, Inc. - Monument, CO

As a Staff Engineer in the DePuy Synthes Monument, CO Process Engineering team, you will play a key role in leading the transformation of manufacturing processes at a facility that delivers critical life restoring orthopedic implants to the world. This position will be responsible for developing and implementing standard work, simplifying value adding activities, streamlining non-value adding activities, implementing robust process controls, and establishing requirements for process control systems. The incumbent will champion manufacturing practices rooted in Lean Manufacturing and Quality by Design that make cGMP an integral part of the daily routine. The ideal candidate will demonstrate prior experience implementing transformational change to achieve world class performance in a cGMP regulated production environment. DePuy Synthes Inc, part of the Global Orthopedics Group within Johnson & Johnson Medical Devices is the largest, most innovative, and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, DePuy Synthes is agile and well-equipped to meet the needs of today's evolving health care environment. Job Duties Provide direction and technical support in identifying continuous improvements to manufacturing operations and implementing new technologies including development of processes, researching current and emerging technologies and evaluating process quality, cost, capacity and capability alternatives. Provide direction in supporting the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost. Lead complex engineering projects to deliver optimized manufacturing processes and systems. Lead and participate in complex investigations, develop plans and execute tasks to solve process problems. Use quality systems, including Nonconformance (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA) to drive continuous improvement. Define and implement process controls, including ERP master data, standard operating procedures, and production record keeping systems. Develop process validation strategy for complex processes. Author and execute engineering studies, process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation). Work schedule is standard business hours (Mo Fr, 8:00 5:00). Must be willing to support 24x7 manufacturing and perform other related duties as required. Must be willing to support global projects, including up to 10% travel. Qualifications A minimum of Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Electrical Engineering, Industrial Engineering, or a related degree is required. At least 6 years of engineering project management experience in a cGMP (FDA, EMA, TÜV, PMDA, etc.) regulated environment is required. Demonstrated experience developing and implementing robust manufacturing systems and processes is required. Experience managing multi-year transformational project(s) is required. Strong written and verbal communication and presentation skills is required. Strong organizational and project management skills is required. Strong computer skills, including proficiency with data analysis programs is required. Demonstrated understanding of industrial safety practices is required. Demonstrated cross-functional leadership qualities, including confidence, transparency, integrity, innovation, passion, patience and tenacity is required. Master Degree in Engineering, Business Management or related is preferred. Certification: Six Sigma and/or Lean Black Belt is preferred. Experience implementing integrated digital manufacturing systems per ISA-95 is preferred. Primary Location United States-Colorado-Monument Organization DePuySynthes Products Inc (6149) Job Function Process Engineering Requisition ID 5684171130

7 days 4 hours ago

Johnson & Johnson Services, Inc.


Staff Manufacturing Process Engineer Johnson & Johnson Services, Inc. - Monument, CO, United States


Location: Monument, CO

Company Profile:
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.