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Job Description

About the Role:

As an Automation Engineer I role, you will work in 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, support of PLC, DCS, Manufacturing Execution systems, and ancillary data systems used to control and collect data for multiple building and manufacturing unit operations ensuring uninterrupted 24/7 manufacturing operations and remain within their validated state and regulatory compliance.. 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:

• Be the Primary contact for our Control System operations to MBO groups such as Manufacturing, Engineering, Facilities.
• Provide direct and call support (Analizing online Process Logic, Providing information, diagnosing and troubleshooting incidents, logging activities and reporting out of these support activities) to Shift Mechanics and Manufacturing technicians during operations.
• Perform Routine operational activities including: User Management, Backup and Restore, Security Management, System performance monitoring, Periodic Reviews, Incident and Change management.
• Be accountable for system performance, continuous improvement, and iterative innovation.
• Develop subject matter expertise on assigned unit operations.
• Support tasks and activities related to project engineering for small to medium-scale projects.
• Maintain the design and operability of all PLC, DCS, Manufacturing Execution systems, and ancillary data systems used to control and collect data for multiple building and manufacturing unit operations ensuring uninterrupted 24/7 manufacturing operations and remain within their validated state and regulatory compliance.
• cause unknown with no product impact) complexity. Expectation to carry a smartphone device for immediate assistance.
• Build work orders in Maximo using tools and following Good Engineering Practices (GEP), Good Automated Manufacturing Practices (GAMP), and current Good Manufacturing Practices (cGMP).
• Investigate and document automation related deviations related to compliance and environmental health and safety (EH&S) using business tools/systems like Trackwise.
• Establish causes using tools (5-Whys, Fish-Bone) and identify design solutions as part of Corrective and Preventative Actions (CAPAs) including Standard Operating Procedure (SOP) changes.
• Perform data analysis to identify trends in equipment performance using tools such as PI Historian, Minitab, Excel, Spotfire, and PowerBI.
• Build periodic preventive maintenance (PM) work orders, documenting results through the Maximo business system.
• Perform system & application backups, virus protection, operating system patches
• Help with compliance and safety inspections/audits by compiling and presenting data for the audit committee and auditors.
• Attend daily tier, investigation, design, leadership and strategy meetings to ensure and collaboration.
• Support the project lifecycle (conceptual design, basic design, detailed design) for small and medium-scale projects under the supervision of senior or principal engineers.
• Responsible for delivery of deliverables/solutions, meeting technical quality standards and delivery of engineering solutions that contribute to project success.
• Support front end engineering design (FEED) activities including development of technoeconomic feasibility assessments, options analysis, project proposals, and basis of design related to equipment modifications and continuous improvements.
• Help develop control algorithms, alarm strategy, and sequence of operations.
• Analyze data and create detailed technical reports to inform decision-making.
• Collaborate with external vendors to support troubleshooting activities, feasibility walkthroughs, installation, construction, and maintenance events.
• Maintain drawings, including Piping & Instrumentation Diagrams (P&ID), Physical or Logical Architecture Diagrams, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), or Configuration Specifications (CS)
• Use business tools such as COMOS and Veeva for documentation.
• Participates in in-depth design reviews and risk assessments using basic tools (PHA, JHA) to ensure the robustness and reliability of design solutions.
• Learns industry standards such as, ISA S-88, S-95, GAMP, and ASTM 2500
• Provide support for system development, and testing both software and hardware acceptance tests (SFAT and HFAT) at vendor sites during projects, as required.
• You will learn Programming Standards and draft and build commissioning test protocols (SAT, CTP, IOV) on the floor to establish robust automation implementation and operation using Kneat.
• Review test protocols (CTP, IOV) and support discrepancy resolutions during the execution of installation, operational, and performance qualifications (IOPQ).
• Maintain and review work instructions (WI), standard operating procedures (SOP), guidance, and standards for automation-owned programs, including Building Management System (BMS), Critical Monitoring System (CMS), and Process Control Systems (PCS) for example
• Develop, review, and enhance playbooks to ensure audit readiness.
• Ensure the lifecycle maintenance of equipment specifications, drawings, datasheets, and COMOS database metadata owned by the automation engineering team.

What you bring to Takeda:

• B.S./M.S. in Chemical Engineering, Electrical Engineering, Computer Sciences, or equivalent degree
• Proficiency with Microsoft products; ability to learn additional software applications, as the need arises – TrackWise experience would be ideal.
• Experience in a cGMP Engineering role within pharmaceutical, biotechnology, or other FDA regulated industry.
• Understanding of instrumentation, and its configuration, Industrial Control networking such as Ethernet IP, Profibus, or AS-I networks. Programmable Logic Controller or Distributive Control System programming, and Data Historian and Report Configuration.
• Knowledge in at least one relevant automation system such as Allen Bradley or Siemens PLC platforms, Delta V DCS platform, Schneider Electric or Johnson Controls BMS platforms,iFix, Factory Talk, or ignition SCADA systems, data systems (PI, IP21, Crystal Reports, rtReports, etc.) and data integration solutions (OPC, Kepware, Matrikon, LabX, WebAPI, etc.)
• Establishes rapport, builds relationships that create networks with those individuals and stakeholder groups critical to short and long term goal attainment.
• 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)

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.

#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.

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$56,000.00 - $88,000.00

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.