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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 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.
• This role is consider Hybrid at the Massachusetts Biological Operations (MBO) site of Takeda Pharmaceutical Co. Ltd., A successful candidate will be required to be on-site a minimum of 3 days per week and as business needs require and available for on-call support 24/7.
• Required to carry a cellular device and be available to support requirements at all sites.
• Ability to work at all Takeda MABIOPs locations (Cambridge, N Reading, Belmont and Lexington)
• Regulatory Compliance: Maintaining compliance with cGMP and safety standards is a fundamental aspect of this role, candidates must be capable of gowning into cGMP manufacturing areas and working in a controlled and regulated environment for extended hours, when necessary, ensuring adherence to stringent safety and quality standards.
• Travel: Candidates may be required to travel for business reasons (e.g. training, meetings, factory acceptance testing). Travel may include international travel. Travel should not exceed 20%

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 #LI-MA1

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 - MA - Lexington - BIO OPS

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 - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.