Senior Controls Engineer
Otsuka ICU Medical

Job Description

Position Summary

Provides technical leadership for automated process control systems (APCS) supporting pharmaceutical manufacturing operations, including Fabrication, Filling, Overwrap, Sterilization, Packaging, and Utilities systems. Responsible for improving system performance, reliability, compliance, and safety through evaluation and enhancement of PLC, HMI, and robotic control systems.

Leads troubleshooting, system optimization, and implementation of automation solutions. Works closely with Maintenance, Operations, and Validation to ensure systems remain in a validated state and operate efficiently within a GxP-regulated environment. Provides project leadership for automation-related capital and continuous improvement initiatives.

Essential Duties & Responsibilities

• Analyzes, designs, and implements control systems for complex manufacturing equipment, including PLCs, HMIs, SCADA, and robotic systems (e.g., Fanuc).
• Develops functional specifications, control narratives, and design documentation for automation systems in compliance with site and corporate standards.
• Provides technical leadership (SME) for APCS across multiple manufacturing processes; leads troubleshooting of equipment and system issues.
• Evaluates existing automation systems and implements improvements to increase reliability, efficiency, and compliance.
• Develops and executes automation strategies for capital projects, including scope development, design, FAT, SAT, commissioning, and validation support.
• Integrates multiple subsystems (PLC, HMI, vision systems, robotics, and field devices) into cohesive, reliable control systems.
• Ensures all automation changes are performed in accordance with change control and software validation procedures).
• Leads and manages automation project timelines, provides status updates, and communicates risks to site leadership.
• Supports validated systems by maintaining software lifecycle documentation, backups, version control, and audit readiness.
• Identifies and drives continuous improvement initiatives for automation systems and manufacturing processes.
• Collaborates with Maintenance to improve equipment uptime, PM strategies, and troubleshooting effectiveness.
• Provides technical training and knowledge transfer to engineers, maintenance, and operations personnel.
• Leads or supports deviation investigations, root cause analysis, and CAPA implementation related to control systems.
• Communicates effectively across functions and escalates risks or issues as needed.
• Works on special projects as assigned.

Knowledge, Skills & Qualifications

• Advanced knowledge of PLC programming (e.g., Rockwell, Siemens), HMI/SCADA systems, and industrial networking
• Experience with robotic systems (e.g., Fanuc), vision systems, and motion control preferred
• Strong understanding of automation system integration and troubleshooting
• Working knowledge of GxP regulations, validation practices, and change control processes
• Ability to manage multiple projects and priorities in a regulated manufacturing environment
• Strong analytical and problem-solving skills with ability to implement practical, compliant solutions
• Effective communication and cross-functional collaboration skills

Education and Experience

• Bachelor's Degree in Engineering required (Electrical, Computer, or related discipline preferred)
• Minimum of 10 years of experience in controls/automation engineering
• Experience in pharmaceutical or other regulated manufacturing environments strongly preferred
• Experience with validated systems and software lifecycle management preferred

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• This is largely a sedentary role
• Work is performed in both office and manufacturing/cleanroom environments
• Must be able to occasionally move and lift objects up to 25 lbs

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger-a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement:

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants

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