Manufacturing Systems Lead
3 weeks ago
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world.
DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.
For more information, visit www.depuysynthes.com .
DePuy Synthes Joints platform manufacturing sites are in Raynham & Bridgewater MA USA, Warsaw IN USA, Cork Ireland, Blackpool UK, Leeds UK, Suzhou China, and a new site under construction in Costa Rica.
Position Summary Reporting to the MAM (Make Asset Management) Site Lead, the Manufacturing Systems (MS) Engineer is responsible for the development and lifecycle management of Manufacturing Systems and data (Manufacturing Execution Systems (MES), DNC, OEE, Automation Network, OSI PI, Cybersecurity, etc) within Leeds & Blackpool.
This role partners with the Manufacturing Systems global standards team, IT/JJT, Operations, Tech Ops and Quality to define, implement, and sustain the site Manufacturing Systems and data roadmap, aligned to global strategy & standards.
Position duties & responsibilities: • Responsible for managing operational aspects of systems, (e.g.
goals, budget, workflow, performance, system uptime and compliance), ensuring key performance indicators are being met or exceeded, as well as ensuring achievement of team goals within expected standards.
• Work with various partners to understand customer problems, business processes and value to build the sites manufacturing system's and data roadmap & investment plan along with the Digital and Manufacturing Systems council, Operational and IT partners which clearly communicates the journey for change across the sites, leverages existing solutions where relevant and aligns to global standards.
• Provides leadership, including obtaining agreement and funding on site MS projects and priorities, and ensuring that resources, capabilities and processes are in place and projects are completed within time and budget expectations while ensuring safety, quality, standardization and compliance.
• Ensure all manufacturing systems and data are designed, built and run (following system administration requirements) to meet business & standards requirements, in a compliant & cost competitive manner.
Ensure life cycle management of systems are maintained to current supported technology, and upgrade requirements are planned into roadmap.
• Work with the MS Global Standards team, peers from other sites and other J&J technology partners to identify & evaluate new technologies, approaches and processes to address the manufacturing systems needs.
• Provides support or leads as relevant for investigations (Events / CAPA's) and regulatory inspections.
• Manages MS related vendor contracts and/or contract resources.
• Management of system interfaces in scope of MS. • Plans for and manages how systems are supported out of business hours.
• Providing (User) training to users Key Competencies Required • A willingness to be hands-on in all aspects of managing & maintaining manufacturing systems • Flexible work ethic • Ability to influence at various levels of an organization & a strong ability to communicate and collaborate and build relationships with key stakeholders • Excellent communication skills (written and oral) • Change management, project management, and the ability to work effectively and drive alignment in a global environment, internally & externally through strong communication and empowerment.
• Problem solving skills - to assist in maintaining project progress and on design issues • Decision Making is required to make decisions on technical and management issues • Excellent planning and organizing skills • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems • Managing risk and crisis, including investigation, escalation, prioritization and resolution of systems and support issues and developing and managing responses.Qualifications & Experience • Minimum of a Bachelors degree in Engineering, IT or Science area of study.
• Minimum of 3 years of experience in GMP regulated and related position • Project Management Certification OR 2 years of Project management experience • Experience with manufacturing systems requirements, design, deployment, and support • Knowledge of industry standard, guideline and methodologies (ISA 88/95, GAMP) • Fluent English is required • Travel up to 10% (international) • J&J certifications or alternatives - Drive (Digital), PMP, FPX, LEAN or Six Sigma with a proven track record of improving business performance • Knowledge of MedTech processes is highly desirable • Experienced with SDLC methodology, DevOps, understanding of issues covering site architecture, UI and navigation and familiarity with software quality assurance processes.
• Manufacturing experience within Operations, LEAN, or Production • Experience of working in global teams with remote support.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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