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Job Description

Job Title: Senior Automation Engineer

Location: Lexington, MA

About the role:

As a Senior  Automation  Engineer role, you will provide operational, and project support of PLC, DCS, Manufacturing Execution systems, and ancillary data systems used to control  and collect data for multiple building and manufacturing unit operations. You will be the primary contact for our Control System Platforms and be a Subject Matter Expert for control system operations to MBO groups such as Manufacturing, Engineering, Facilities, etc. You will provide support  to our automation operations  team of manufacturing  operations.

How you will contribute:

• Be accountable for system performance, continuous improvement, and large-scale innovation.  

• Be a subject matter expert on multiple assigned unit operations and Develop subject matter expertise on assigned automation platform.   

• Be a consultant to automation engineering and site leadership on major functionality challenges and industry best practices about design, policies, business processes, goals, and objectives.

• Maintain the design and operability of all PLC, DCS, Manufacturing Execution systems, and ancillary data systems used to control and collect data for various building and manufacturing unit operations ensuring uninterrupted 24/7 manufacturing operations and remain within their validated state and regulatory compliance. 

• Support the primary operations team and help troubleshoot and Resolving Issues. 

• Expectation to rotate on call to provide immediate assistance. 

• Accountable for completion of Automation Engineering owned CAPAs and Change Controls.

• Lead the project lifecycle (conceptual design, basic design, detailed design) for small to large-scale projects under the supervision of principal engineers. 

• 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. 

• Use Programming Standards.

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

• Review and approve test protocols (CTP, IOV).     

• Support discrepancy resolutions during the execution of installation, operational, and performance qualifications (IOPQ).

• Develop, Improve and Maintain, 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.

• Demonstrate selecting methods and techniques for obtaining solutions.  Networks with senior internal and external personnel in own area of expertise.

• Normally receive little instruction on daily work, general instructions on new assignments. 

What you bring to Takeda:

• B.S./M.S. in Chemical Engineering, Electrical Engineering, Computer Sciences, or equivalent degree

• Minimum of 5 to 8 years of relevant industrial controls experience and demonstrated accomplishments.

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

• Expertise in Delta