EQUIPMENT ENGINEER II - (BILINGUAL) (TEMPORARY 12 MONTHS)
Johnson & Johnson · Ciudad Juarez, Chihuahua, Mexico
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Project Engineering Job Category: Scientific/Technology All Job Posting Locations: Ciudad Juarez, Chihuahua, Mexico Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Equipment Engineer II (Temporary 12 months) – Bilingual | Process Validation & Statistical Analysis Purpose: The Equipment Engineer is an individual contributor responsible for the equipment Implementation and validation of technology, capable of providing support and/or troubleshooting skills to solve problems to the different business unit equipment. Must be able as needed to direct and lead different projects related to equipment, capacity increase projects for the manufacturing site in accordance with the production and strategic plans. Requirement for the production lines installation, incorporates needs for the existing and new production lines, design changes and process improvements related to capacity increase, quality and process productivity improvement metrics. Leads the planning, execution and monitoring of strategic projects to support the manufacturing and capacity demands. Contributes to key performance indicator achievements and supports company initiatives. Establishes procedures to ensure that manufacturing areas operate safely and contributes to assure the compliance with quality and EH&S procedures. You will be responsible for: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position: Provides technical expertise and assistance to assigned engineers, manufacturing associates, supervisors and technicians during line design, installation and monitoring to ensure a flawless ramp up of production launches. Evaluates and implements new automation technologies into manufacturing operations; designs, selects, and installs hardware and software upgrades. Executes specific automation-related capital projects from design through construction, equipment concept validation and approval. Disposal management of production line assets. Coaches project management teams in the identification of scope changes, including provision of necessary information to support claims for time and cost impact. Leads capital management initiatives, including cost estimating, schedule development, cost-benefit analysis, and technical fitment evaluations. Develops and executes detailed project plans using standard project management tools (charters, Gantt charts, etc.). Responsible for communicating business-related issues or opportunities to the next management level. Supports the evaluation of business plans for project portfolio prioritization. Responsible for following and coaching teams on all Company guidelines related to Health, Safety and Environmental practices, as applicable. For positions with supervisory responsibilities, ensures that subordinates comply with all Company Health, Safety and Environmental guidelines and that the necessary resources are available and maintained in good condition. Manages individual and multiple complex projects simultaneously. Conducts complex assessments to determine regulatory compliance and identify necessary improvements to meet regulatory requirements. Executes the NCR and CAPA processes by documenting, investigating, performing root cause analysis, and implementing corrective and preventive actions for product non-conformances. Creates and updates documentation as required to enhance and adapt quality and manufacturing systems to business needs. Demonstrates high proficiency in validation strategy and execution, delivering consistent results in equipment implementation and/or process improvements. Equipment Engineering SpecialtiesThe Equipment Engineer supports multiple business areas and, depending on the role, responsibilities may be adjusted to meet strategic business needs, including Critical Equipment, Proactive Engineering and Projects Engineering. Critical Equipment Troubleshoots and tests new equipment. Monitors and analyzes data to identify potential issues or opportunities for improvement. Maintains and administers manufacturing equipment control systems in support of daily process operations. Executes machine and process improvements on automation systems post-release to support operational objectives such as yield, uptime and reliability. Writes and reviews documentation, including procedures, special instructions, qualification plans and reports, and corrective action plans. Ensures safe working conditions and practices within the department and supports compliance with plant safety requirements. Participates as a project implementation team member and provides manufacturing support for systems directly interconnected with equipment. Proactive Engineering Ensures regulatory compliance through validation and verification processes. Determines processes requiring validation, develops plans and analysis criteria, executes validation activities, and performs final analysis and acceptance. Establishes governance for ongoing quality actions, monitoring and appropriately communicating potential implementation risks. Facilitates CAPA and non-conformance meetings and prepares investigation documentation associated with manufacturing compliance issues. Performs investigations and root cause analyses to identify solutions and necessary corrective and preventive actions. Executes investigation processes from initiation to closure, including stakeholder identification, timeline development, escalation and change management. Creates or updates manufacturing procedures and documentation to incorporate process improvements. Identifies and eliminates potential compliance gaps in manufacturing processes and documentation. Provides training and support to ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including implementation of related actions. Provides support during internal and external audits. Develops strategies and implementat
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