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Job Description

Job Title: Principal Automation Hardware Engineer

Location: Lexington, MA

About the role:

As a Principal Automation Hardware Engineer, you will be a part of the Automation  engineering group located at the Massachusetts Biological Operations (MBO) site of Takeda Pharmaceutical Co. Ltd. You will be responsible for operational, project, and strategic  support of PLC, DCS, Manufacturing Execution systems, and ancilary data systems used to control  and collect data for multiple building and manufacturing unit operations. You will report to the Automation Lead. 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.

How you will contribute:

• Support the Automation Engineering team in providing technical ownership to maintain the design and operability of all PLC, DCS, Manufacturing Execution systems, and ancilary 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.

• Mentor Automation engineers in troubleshooting equipment issues of varying complexity.

• Promote business case development for OPEX/CAPEX investments in automation system improvements incl. Total Cost of Ownership (TCO) calculations.

• Support Automation Engineering team in gathering  requirements from Stakeholders - such as from Quality, Manufacturing, Reliability, Maintainability, Process, and EHS – to develop Basis of Designs, specifications and designs for Process Control Systems, Process Instrumentation and Process Safety Systems and Devices.

• Gather proposals  including budgetary and schedule estimates from vendors for project scopes.

• 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.

• Use industry standards such as, ISA S-88, S-95, GAMP, and ASTM 2500.

• Provide support for system development, implementation, and testing both software and hardware acceptance tests (SFAT and HFAT)  at vendor sites during projects, as required.

• Draft and implement commissioning test protocols (SAT, CTP, IOV) on the floor to establish robust  automation implementation and operation using Kneat.

• Important member of the Automations Engineering Leadership Team and works in collaboration with the team to lead Automation Engineering strategic goals.

• Participate in the Community of Practice (CoP) through sharing of best practices and lessons learned.

• Sponsor the evaluation and selection of new, state-of-the-art systems, technologies and data acquisition, analysis, and reporting tools.

• Exercise wide latitude in determining objectives and approaches to critical assignments.

What you bring to Takeda:

• B.S./M.S.  in Chemical Engineering, Electrical Engineering, Computer Sciences, or equivalent degree, a minimum of 12 years of relevant industrial controls experience and demonstrated accomplishments.

• Experience with cGMP Engineering role within pharmaceutical, biotechnology, or other FDA regulated industry. 

• Experience designing and maintaining low voltage control panel standards.

• Expert 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 system architecture.

• Expert understanding of Control Panel Design, Fabrication and Installation.

• Expert understanding of IT/OT network and infrastructure design and maintenance.

• Expert Understanding of Server Management

• Experience with endpoint security – anti-malware, Zscalar, System Hardening Firewall configuration, segmentation experience (evaluation of net flows to determine comm patterns before breaking them with an internal firewall).

• Experience with automationed patching through systems like System Manager or SolarWinds.

• Expertise in multiple 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.).

• Demonstrated experience of Windows OS, Networking & System Security Fundamentals

• In-depth knowledge of core principles in multiple engineering disciplines (e.g. process engineering, plant engineering, automation engineering), facility design and Good Engineering Practice (GEP).

• Demonstrated experience with the application of project management methodology and delivering solutions that meet business objectives for complex programs/initiatives.

• Familiarity working in a cGMP environment to ensure compliance with company policies and procedures.

• Maintain continuous awareness around cGMP and quality; follow compliance requirements.

• Travel: You may travel for business reasons (e.g. training, meetings, factory acceptance testing).  Travel may include international travel. Travel should not exceed 20%.

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.

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.

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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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U.S. Base Salary Range:

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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