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Job Description

Job Title: Sr. Automation Engineer

Location:  Round Lake, IL

About the role:

The Automation Engineer in this role will focus on Serialization and automation for packaging and filling.  This role will be responsible for ensuring the optimal and cost-effective performance of Systech serialization systems, vision inspection systems, and other automation technologies on filling and packaging lines at the Round Lake Site. This role requires close collaboration with Maintenance and Operations teams to provide timely troubleshooting support for production issues, ensuring minimal downtime and continuous improvement. The engineer will own the resolution of recurring issues, drive root cause analysis (RCA)desn, and implement corrective and preventive actions (CAPA) to enhance system reliability. Additionally, this role involves managing the Systech Guardian database, maintaining the IT network infrastructure for serialization systems (Advisor and Sentri), controlling user access, and supporting engineering and manufacturing in packaging artwork and labeling changes.

How you will contribute:

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

• Schedule execution of Vision inspection and Serialization systems, from medium to large capital projects by working in cross-functional teams as the engineering lead/representative for the automation packaging automation area.

• Assess existing equipment and control systems in the various manufacturing areas and determine the required changes to meet the design and reliability requirements.

• Develop and review the automation of the manufacturing process, support equipment and systems, design drawings and documents, and equipment 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 readiness for project execution. Create or update technical support specifications (Design/Functional/System) related to project assignments.

• Supervise contractors and junior-level engineering personnel on projects and activities.

• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem-solving capability.

• Provide hands-on technical support for diagnostics and troubleshooting of automation systems during production, working closely with maintenance to ensure rapid issue resolution and drive continuous design improvements. Lead the design, implementation, and validation of changes to Systech serialization and vision systems, ensuring strict adherence to change control standards and minimizing impact on ongoing operations. Perform events investigation related to automation system and implement the corrective Develop standard operating procedures (SOPs) and work instructions for packaging and filling and processing systems.

• Develop and deliver targeted training on critical automation systems to maintenance and production personnel, ensuring skill enhancement and improved troubleshooting capability.

What you bring to Takeda:

• Bachelor's degree in Engineering (preferably in Electrical, Mechanical, or Mechatronics Technology).

• 5+ years of related experience in FDA regulated environment.

• Strong programming/design “hands-on” experience with Automation Systems and Trac and Trace systems.

• Experience supporting of control systems in a Pharmaceutical Good Manufacturing Practice (GMP) environment.

Key Skills, Abilities, and Competencies

• Must demonstrate a track record of successfully executing automation and control system projects supporting operating facilities, in a FDA-regulated manufacturing environment.

• Possess knowledge of core principles in various engineering disciplines including manufacturing .

• Must have basic knowledge in the automation of pharmaceutical or food processing facilities.

• Must have familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.

• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.

• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.

• Must have proficient computer skills and be experienced using Rockwell applications such as Studio 5000 and FactoryTalk View ME, Systech Serialization Sofware, Cogenx and Fanuc Robotics applications   

• Experienced in Barcode design, printing, and management using BarTender software including Artwork review of label copy changes while using FOCUS artwork management system.

• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.

• Knowledge of programmable logic controllers, industrial controllers, instrumentation, network designs and controls is highly desirable.

• Ability to prioritize multiple tasks and work on multiple projects simultaneously.

• Participate in rotating after-hour daily, weekend and holiday schedules for emergency escalation support calls related to troubleshooting and maintenance assistance with technical issues.

• Must be a self-starter, detail oriented and able to work independently with minimal supervision.

• Must embrace working in a fast-paced, team-oriented, cross-functional environment.

• Must possess the ability to manage commitments and display eagerness to learn and continuously improve.

Other Job Requirements

• Will occasionally work in a cleanroom environment and wear special garments (requires removal of make-up and jewelry).

• Must occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.

• Will occasionally work around chemicals such as alcohol, acids, caustics, buffers and bleach that may require respiratory protection.

• May occasionally climb ladders and stairs to higher elevations.

• May occasionally work weekends, evenings, and off-hours, for extended periods.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• 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.

#GMSGQ  #ZR1 

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.

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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.

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