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Job Description

About the role:

The Senior Automation Engineer II role is a hybrid position and is part of the Automation engineering group located at the Massachusetts Biological Operations (MBO) site of Takeda Pharmaceutical Co. Ltd. The scope of responsibility will include operational and project support of PLC, DCS, Manufacturing Execution systems, and ancilary data systems used to control and collect data for multiple building and manufacturing unit operations. The main manufacturing systems include incubators, bioreactors, chromatography skids, filtration skids, media and buffer preparation vessels, intermediate totes, CIP and caustic distribution skids, COP washers, and autoclaves. You will report to Automation Lead.

How you will contribute:

• You will be the primary contact and subject matter expert for Control System Platforms, supporting Manufacturing, Engineering, and Facilities teams.
• Provide technical guidance to automation engineering teams, ensuring system performance, compliance, and continuous improvement.
• Maintain the design, operability, and validated state of PLC, DCS, MES, and ancillary data systems for uninterrupted 24/7 operations.
• Troubleshoot and resolve automation-related issues, participate in on-call rotations, and build work orders using systems like Maximo.
• Investigate and document automation deviations, establish causes using tools, and implement corrective and preventive actions (CAPAs).
• Perform advanced data analysis to identify equipment performance trends using tools like PI Historian, Minitab, Excel, Spotfire, and PowerBI.
• Lead automation project lifecycles, including scoping, design, implementation, and commissioning, while ensuring alignment with site priorities and strategic goals.
• Maintain automation documentation, including drawings, specifications, and SOPs, while leveraging systems like COMOS and Veeva.
• Ensure compliance during audits, author regulatory filings, and support safety inspections through comprehensive data preparation.
• Collaborate with vendors to assess new technologies, define project requirements, and ensure successful equipment installations and upgrades.
• Lead the development of control algorithms, alarm strategies, and sequence of operations while adhering to industry standards like ISA S-88 and S-95.
• Support system lifecycle maintenance, ensuring automation implementations and preparing for audit readiness through playbooks and training materials.

What you bring to Takeda:

• Bachelor's degree in Chemical Engineering, Electrical Engineering, Computer Sciences, or equivalent, with 8–10 years of relevant industrial controls experience and accomplishments.
• Proficiency in cGMP Engineering within FDA-regulated industries (pharmaceutical or biotechnology) and strong understanding of Good Engineering Practices (GEP).
• Expertise in automation systems (e.g., Allen Bradley, Siemens PLC, DeltaV DCS, iFix, SCADA systems) and data/integration solutions (e.g., PI, OPC, WebAPI) with knowledge of instrumentation and industrial control networks (Ethernet IP, Profibus).
• Experience in project management methodologies, delivering solutions for complex programs, and adhering to strict schedules while mitigating risks.
• Strong technical skills in Windows OS, networking, system security fundamentals, and software applications like TrackWise and Microsoft tools.
• Performance-driven, and focused on building relationships, ensuring compliance, and with urgency.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow