Controls Designer

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.
• Perform other duties as assigned to support business objectives.

Supervision

The Controls Designer provides direct technical leadership and work direction for Controls Specialists and other technical personnel. This role may function as a project leader, mentor, or functional leader for automation initiatives and is expected to positively influence organizational performance through technical expertise and leadership.

Education

Associate’s degree in electrical engineering technology, Automation Technology, Mechatronics, Industrial Technology, or a related technical field.

Experience

Required

• Minimum of five (5) years of experience designing, programming, implementing, and supporting industrial automation and control systems.
• Experience leading technical projects within a manufacturing environment.
• Experience with automation system troubleshooting and continuous improvement initiatives.
• Experience developing and mentoring technical personnel.

Preferred

• Experience within the medical device, pharmaceutical, or other regulated manufacturing industries.
• Experience with system validation including IQ/OQ/PQ requirements.
• Experience managing third-party automation vendors, contractors, and system integrators.
• Experience supporting capital projects from concept through execution.

Knowledge, Skills and Abilities

Technical Competencies

• Advanced PLC programming, troubleshooting, and system integration.
• SCADA and HMI development and support.
• Industrial networking technologies and communication protocols.
• Machine vision system implementation and optimization.
• Motion control and servo system applications.
• Electrical power distribution and control systems.
• Electrical schematic design and drafting.
• Industrial automation cybersecurity principles.
• Validation and change control processes.
• Structured problem-solving and root cause analysis methodologies.
• Advanced proficiency with Microsoft Office applications and other engineering software tools.

Leadership Competencies

• Technical leadership and mentoring.
• Project management and execution.
• Cross-functional collaboration.
• Effective verbal and written communication.
• Strategic and analytical thinking.
• Decision-making and problem-solving.
• Change management and continuous improvement leadership.
• Ability to influence and develop others

Certifications & Special Requirements

• Radiation Certification must be obtained within 12 months of assuming the position.
• Position is contingent upon successfully completing all required background screening requirements, including FBI background verification as applicable.
• Must be able to speak, read, and write English proficiently

Physical Demands

Work Environment: Fast-paced manufacturing environment requires a high degree of attention and technical focus. Exposure to noise, heat, dust, chemicals, and manufacturing equipment may occur. Required use of personal protective equipment, including safety glasses, hearing protection, safety footwear, and other site-required PPE. Occasional lifting, equipment inspection, and field troubleshooting activities may be required. Occasional off-shift, weekend, or emergency support may be required.