Full-Time Senior Automation Engineer
Job Description
About the role:
The Automation Engineer in this role will focus on Serialization and automation for packaging and filling. You will ensure the cost-effective performance of Systech serialization systems, vision inspection systems, and other automation technologies on filling and packaging lines at the Round Lake Site. We are looking for close collaboration with Maintenance and Operations teams to provide troubleshooting support for production issues, ensuring minimal downtime and continuous improvement. The engineer will lead the resolution of recurring issues, improve root cause analysis (RCA)desn, and implement corrective and preventive actions (CAPA) to enhance system reliability. Additionally, you will manage 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. You will report to the Associate Director of Engineering.
How you will contribute:
Independently lead the execution of process and production systems support, ensuring resolution of issues and minimizing production downtime. 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 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.
Be 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. Maintain technical support specifications (Design/Functional/System) related to project assignments.
Manage contractors and junior-level engineering personnel on activities.
Provide technical support for automation diagnostics and troubleshooting, collaborating with maintenance for quick resolutions and design improvements. Lead design, implementation, and validation of changes to Systech serialization and vision systems, adhering to change control standards to minimize operational impact. Investigate automation system events, implement corrections, and develop SOPs and work instructions for packaging, filling, and processing systems.
Develop and deliver 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.
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.
Must demonstrate experience implementing automation and control system projects supporting operating facilities, in a FDA-regulated manufacturing environment.
Have knowledge of core principles in multiple 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 software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Display an understanding of theories/practices used by other disciplines outside primary area of expertise.
Must have and be experienced using Rockwell applications such as Studio 5000 and FactoryTalk View ME, Systech Serialization Software, 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.
Knowledge of programmable logic controllers, industrial controllers, instrumentation, network designs and controls is.
Participate in rotating after-hour daily, weekend and holiday schedules for emergency escalation support calls related to troubleshooting and maintenance assistance with technical issues.
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. You may:
May 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 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.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.
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