Automation Engineer

Automation Engineer

Requirements

• 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
• 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.)

Responsibilities

• Be the Primary contact for our Control System operations to MBO groups such as Manufacturing, Engineering, Facilities
• Provide direct and call support (Analyzing 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
• 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
• Provide support for system development, and testing both software and hardware acceptance tests (SFAT and HFAT) at vendor sites during projects, as required
• 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)
• 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

Preferred Qualifications

• TrackWise experience would be ideal
• Ability to work at all Takeda MABIOPs locations (Cambridge, N Reading, Belmont and Lexington)