Automation Engineer

Takeda•Lexington, MA

11d•$89,419 - $100,100•Hybrid

About The Position

Shire Human Genetic Therapies, Inc. is seeking an Automation Engineer with the following duties: provide operational and project engineering support for PLC, DCS, MES, and ancillary automation systems supporting cGMP manufacturing operations; serve as technical point of contact for assigned automation platforms, supporting manufacturing, engineering, facilities, and quality teams during operations and on-call rotations; ensure system operability and validated state through troubleshooting, performance monitoring, alarm analysis, backups, user management, patching, and preventive maintenance; investigate automation deviations and change controls using TrackWise, perform root cause analysis, and support corrective and preventive actions; support automation projects through conceptual, basic, and detailed design, scope definition, requirements development, and implementation for small to medium projects; support front-end engineering design activities including feasibility assessments, options analysis, project proposals, and basis of design documentation; develop and support control algorithms, alarm strategies, and sequences of operations for automated manufacturing systems; draft and execute commissioning and qualification protocols including SAT, CTP, IOQ, and IOV, supporting discrepancy resolution; Create and maintain automation documentation including P&IDs, URS, FRS, CS, and architecture diagrams using Veeva and COMOS; collaborate with external vendors on system design, testing, installation, commissioning, maintenance activities, and technical proposal reviews; participate in cross-functional meetings to support operations, investigations, design reviews, and project execution aligned with regulatory and business requirements; up to 40% remote work allowed.

Requirements

Bachelor’s degree in Electronics and Instrumentation or related field.
2 years of related work experience.
Execute online and offline automation code testing for PLC/HMI-based control systems using approved functional and design specifications.
Perform deviation investigations and document corrective and preventive actions (CAPAs) using root cause analysis tools such as 5-Whys in a regulated manufacturing environment.
Draft, update, and execute commissioning and validation documentation, including IOQ protocols, test scripts, and functional specifications, to support automated manufacturing systems.
Troubleshoot and support distributed control systems by analyzing alarms, system faults, and process behavior to maintain operational continuity.

Responsibilities

Provide operational and project engineering support for PLC, DCS, MES, and ancillary automation systems supporting cGMP manufacturing operations.
Serve as technical point of contact for assigned automation platforms, supporting manufacturing, engineering, facilities, and quality teams during operations and on-call rotations.
Ensure system operability and validated state through troubleshooting, performance monitoring, alarm analysis, backups, user management, patching, and preventive maintenance.
Investigate automation deviations and change controls using TrackWise, perform root cause analysis, and support corrective and preventive actions.
Support automation projects through conceptual, basic, and detailed design, scope definition, requirements development, and implementation for small to medium projects.
Support front-end engineering design activities including feasibility assessments, options analysis, project proposals, and basis of design documentation.
Develop and support control algorithms, alarm strategies, and sequences of operations for automated manufacturing systems.
Draft and execute commissioning and qualification protocols including SAT, CTP, IOQ, and IOV, supporting discrepancy resolution.
Create and maintain automation documentation including P&IDs, URS, FRS, CS, and architecture diagrams using Veeva and COMOS.
Collaborate with external vendors on system design, testing, installation, commissioning, maintenance activities, and technical proposal reviews.
Participate in cross-functional meetings to support operations, investigations, design reviews, and project execution aligned with regulatory and business requirements.