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Job Description

About the role:

As an Automation Engineer, you will serve as the technical owner for process and utility systems, ensuring reliable and effective automation throughout operations. You will partner with Process Engineering to support equipment qualification, ongoing operations, deviation resolution, maintenance activities, and system decommissioning, helping to drive process performance, compliance, and continuous improvement.

How you will contribute:

• Create engineering deliverables including: P&IDs, Instrument Data Sheets, Functional Specifications, Panel Drawings, Network Architectures, Standard Operating Procedures, etc.

• Implement system modifications under cGMP change control

• Develop and execute Factory Acceptance Tests (FAT), commissioning protocols, and qualification protocols.

• Support software lifecycle, electronic batch records and electronic signature compliance efforts

• Participate in investigations into system deviations and implement corrective actions and preventative actions

• Develop, evaluate, and implement engineering solutions to complex problems

• Stay current with automation and IT best practices and technologies as related to site activities

• May serve as project manager on small sized projects (<$1M)

• Assist lead engineers in development and implementation of programs related to system qualification, asset management, project execution and GEPs

• Interface with various roles and departments to accomplish project goals

• Work under supervision and have the ability to plan, prioritize work, and know when to escalate issues.

• Complete mandatory training within required timeframe

• Perform other duties as assigned

What you bring to Takeda:

•  Bachelor of Science degree in Engineering or related field

• Preferred education is Bachelor in Chemical Engineering or Electrical Engineering

• 1-5 years as an engineer with process automation focus preferred

• Experience working in FDA regulated industry utilizing cGMP preferred

• Familiarity with PLC programming and SCADA configuration

• Familiarity with Batch-based control systems and Data Historian systems, SQL databases, Scripting languages (VB, etc.) preferred

• Familiarity with a variety of instrumentation and sensing technologies related to pharmaceutical manufacturing

• Must have a demonstrated track record of successfully participating in implementation of control system components and strategies.

• Hands on experience with the operation, support, or design of the following systems:   bioreactors, centrifugation, chromatography, tangential flow filtration, Clean-in-Place systems, autoclaves, or clean utility systems preferred

• Knowledge of Process Engineering and Electrical Engineering Concepts, like fluid dynamics, thermodynamics, and power systems a plus

• Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.

• Knowledge of IT practices with respect to Windows Operating Systems and Networking a plus

• Embrace working in a fast-paced, team-oriented, cross-functional environment

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 su