Controls Designer

Becton Dickinson USA NE - Holdrege Updated 8 October 2026
MedTechPharmaRegulatory AffairsQuality Assurancegmpemafdaiso 13485croinform

Job description

&#xa;&#xa; We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. &#xa;&#xa; Job Description Job Description Summary Primary Function: The Controls Designer is responsible for leading the design, development, implementation, validation, maintenance, and continuous improvement of automation and control systems across the Sterilization operation. This position serves as the site technical authority for industrial controls, automation architecture, machine vision systems, motion control applications, SCADA systems, and manufacturing system integration. The Controls Designer provides technical leadership for automation initiatives that improve safety, quality, reliability, compliance, throughput, and operational efficiency while ensuring adherence to applicable regulatory, quality, and corporate engineering standards. Secondary Function: The Controls Designer serves as a mentor and technical leader for Controls Specialists, technicians, engineers, and manufacturing personnel. This role is responsible for developing technical capability within the organization, establishing standardized controls practices, driving innovation, and providing expert-level troubleshooting support for complex automation and manufacturing challenges. Key Responsibilities: Automation & Controls Leadership Serve as the site subject matter expert for automation, industrial controls, machine vision, motion control, and manufacturing system integration. Develop and maintain site controls standards, architecture, and best practices. Lead the design, programming, commissioning, validation, and lifecycle management of control systems. Research, evaluate, and implement automation technologies to improve operational performance. Ensure controls systems remain reliable, sustainable, secure, and aligned with business objectives. Technical Leadership & Development Provide leadership, coaching, and mentoring to Controls Specialists, technicians, and engineering personnel. Support development and execution of advanced technical training programs that strengthen organizational capability. Facilitate knowledge transfer and promote continuous learning within the technical organization. Lead technical problem-solving activities and provide guidance during critical equipment or process issues. Project Leadership Lead multiple automation and capital projects from concept through implementation and post-launch support. Develop project scopes, budgets, schedules, equipment specifications, and Bills of Material (BOMs). Coordinate activities with internal stakeholders, suppliers, contractors, and system integrators. Manage Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), startup activities, and project validation deliverables. Provide regular project status updates and ensure projects meet scope, schedule, and budget objectives. Manufacturing Support Provide expert troubleshooting support for PLCs, HMIs, SCADA systems, industrial networks, machine vision systems, and automated equipment. Lead root cause investigations of automation-related equipment failures and quality issues. Drive process improvement initiatives that enhance safety, quality, throughput, and equipment reliability. Support manufacturing operations to ensure uninterrupted production and rapid issue resolution. Compliance & Quality Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, applicable regulations, and corporate quality standards. Support validation activities, including IQ/OQ/PQ protocols and change management processes. Maintain system documentation, software revisions, validation records, and technical specifications. Support internal audits, external audits, and regulatory inspections as required. Ensure automation systems are maintained in a validated state throughout their lifecycle. Cross-Functional Collaboration Collaborate effectively with Operations, Engineering, Quality, Regulatory Affairs, Information Technology, Maintenance, and Supply Chain teams. Support enterprise initiatives related to controls standardization and automation modernization. Promote and maintain a culture of safety, accountability, teamwork, and continuous improvement. General Responsibilities: Support compliance with Nebraska Title 180, Control of Ionizing Radiation . Serve as a technical resource during off-shift or emergency situations when required. Communicate effectively and professionally with associates at all organizational levels. Adhere to all company policies, quality standards, safety requirements, and regulatory obligations. Maintain regular and reliable attendance. <li style="color:black !im

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