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Job Description

About the role

The Principal Serialization Automation Engineer plays a critical role within the Automation and Packaging Engineering Department, ensuring the optimal and cost-effective performance of Systech serialization systems, vision inspection systems, and other automation technologies across filling and packaging lines at the Round Lake site.

This position requires close collaboration with Maintenance and Operations teams to provide timely, hands-on troubleshooting support for production issues—minimizing downtime and driving continuous improvement. The engineer will take ownership of recurring issues, lead root cause analysis (RCA), and implement corrective and preventive actions (CAPA) to enhance system reliability and performance.

In addition to technical support, the role includes managing the Systech Guardian database, maintaining the IT network infrastructure for serialization systems (Advisor and Sentri), and overseeing user access controls. The engineer will also support engineering and manufacturing teams in packaging artwork and labeling changes, ensuring compliance and operational readiness.

How you will contribute

• Independently lead the execution of process and production systems support, ensuring timely issue resolution and minimizing production downtime. Proactively identify and implement system improvements through data analysis, technical expertise, and industry best practices to enhance reliability and operational efficiency.

• Manage the execution of Vision Inspection and Serialization systems for medium to large capital projects, serving as the engineering lead for packaging automation within cross-functional teams.

• Evaluate existing equipment and control systems across manufacturing areas and determine necessary modifications to meet design and reliability standards.

• Develop and review automation strategies for manufacturing processes, support equipment, and systems. This includes preparing design documentation, drawings, and procurement packages.

• Serve as a technical approver for protocols and support documentation (e.g., engineering change requests, system change forms), ensuring compliance with validation requirements and project readiness.

• Create or update technical specifications (Design, Functional, System) aligned with assigned project scopes.

• Supervise contractors and junior engineering staff on project execution and daily activities.

• Demonstrate a commitment to continuous improvement by expanding job knowledge, technical proficiency, and problem-solving capabilities within the biopharmaceutical industry.

• Provide hands-on technical support for diagnostics and troubleshooting of automation systems during production. Collaborate closely with maintenance teams to ensure rapid resolution and drive continuous design enhancements.

• Lead the design, implementation, and validation of changes to Systech serialization and vision systems, ensuring compliance with change control procedures and minimizing operational disruptions.

• Investigate automation-related events and implement corrective actions. Develop standard operating procedures (SOPs) and work instructions for packaging, filling, and processing systems.

• Design and deliver targeted training programs on critical automation systems for maintenance and production personnel to enhance troubleshooting capabilities and operational knowledge.

What you bring to Takeda

• A Bachelor's degree in Engineering, preferably in Electrical, Mechanical, or Mechatronics Technology, with a minimum of 10 years of relevant experience in an FDA-regulated environment.

• Proven hands-on experience in programming and design of Automation Systems and Track and Trace systems.

• Demonstrated experience supporting control systems within a GMP-compliant pharmaceutical manufacturing environment.

• A strong track record of successfully executing automation and control system projects in FDA-regulated manufacturing settings.

• Solid understanding of core engineering principles across multiple disciplines, particularly in manufacturing.

• Foundational knowledge of automation in pharmaceutical or food processing facilities.

• Familiarity with industry standards and regulations, including batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.

• Ability to apply cross-disciplinary engineering concepts and practices beyond your primary area of expertise.

• Excellent organizational, verbal, and written communication skills, with the ability to effectively engage cross-functional teams and leadership with minimal guidance.

• Proficiency in using Systech Serialization Software and Cogenx Insight.

• Experience in barcode design, printing, and management using BarTender software, including label copy review via the FOCUS artwork management system.

• Strong interpersonal skills and a collaborative mindset to thrive in team-based environments.

• Working knowledge of programmable logic controllers, industrial controllers, instrumentation, network design, and system software is highly desirable.

• Ability to manage multiple priorities and projects simultaneously in a fast-paced environment.

• Willingness to participate in rotating after-hours, weekend, and holiday support schedules for emergency troubleshooting and maintenance.

• Self-starter with strong attention to detail and the ability to work independently with minimal supervision.

• Enthusiasm for working in a dynamic, cross-functional team environment and a commitment to continuous learning and improvement.

Other Job Requirements

• Occasional work in cleanroom environments requiring special garments (e.g., removal of makeup and jewelry).

• Use of personal protective equipment (e.g., hard hats, safety shoes, safety glasses, earplugs) in designated areas.

• Occasional exposure to chemicals such as alcohol, acids, caustics, buffers, and bleach, which may require respiratory protection.

• Ability to climb ladders and stairs to access elevated work areas.

• Flexibility to work weekends, evenings, and extended hours as needed.

About our Round Lake Facility:

Takeda's manufacturing facility in Round Lake, Illinois, is an integral part of Takeda’s Plasma Network. Close in proximity to both Chicago and Milwaukee, the state-of-the-art facility specializes in producing Flexbumin through the GALAXY manufacturing process. Flexbumin is albumin, contained in a flexible pouch, for patients who experience a loss of plasma volume from situations such as trauma, surgery, blood loss and burns. Round Lake supplies its product to patients all over the world, with key markets in the U.S., China, and India.

Join us to make a difference.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - IL - Round Lake - Drug Delivery

U.S. Base Salary Range:

$111,800.00 - $175,670.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes