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Lexington, Kentucky, United States
Onsite
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Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies, Inc. for the following job opportunity:
JOB LOCATION: Lexington, MA
POSITION: Automation Engineer
POSITION DESCRIPTION: 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.
The estimated salary range reflects an anticipated range for this position. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
REQUIREMENTS: Bachelor’s degree in Electronics and Instrumentation or related field, plus 2 years of related work experience. Prior experience must include: 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.
Full time. $89,419 to $100,100 per year.
Qualified applicants can apply at https://jobs.takeda.com. Please reference job # R0183572. EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.