Senior Automation Engineer at Alnylam Pharmaceuticals in Cambridge, Massachusetts

Job Description:

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

This position is responsible for project leadership and daily automation support of the Manufacturing, Utilities and Building control systems at the Cambridge, MA and Norton, MA facilities. This collection of systems spans GMP and non-GMP systems, design, build, commission and then lifecycle support as a system owner. The role will require effective collaboration and support to functional areas such as Process Sciences, Manufacturing, Quality, Process Engineering, Facilities, Validation and other applicable stakeholders. Additional cross-site collaboration and support may be required for other Alnylam locations, including Norton and Alewife.

Key Responsibilities

• Leads the planning and execution of Automation systems being implemented at Kendall Square, Cambridge, MA facility
• Applies advanced Automation engineering principles to the design and implementation of system modifications, experiments and/or capital projects; develops, organizes, analyzes and presents interpretation of results for operational issues or Automation engineering projects of significant scope and complexity
• Automation Project Leader for site projects including expansions and upgrade activities, providing day to day technical leadership to the project team in all project phases (design, delivery, startup, commissioning, validation and operational support
• Manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems, facilities or processes
• Provides Subject Matter Expertise for capital projects, including automation system design, control system hardware, equipment design, control panel design, and instrumentation start-up and troubleshooting
• Develops company automation capabilities, including development of technical standards, guidelines, and procedures in accordance with industry best practices for executing large capital projects
• Supports manufacturing operations, including troubleshooting of operational issues in manufacturing, maintenance, validation, or capital projects
• Promote a culture of safe and compliant design and operation
• Serves as technical process automation leader for large capital projects, interfacing with Alnylam stakeholders and external consultants / contractors
• Reviews and critiques process and automation system designs and support project lifecycle activities in alignment with an ASTM E2500 model
• Manages all aspects of automation system design and integration, including specification development, integration, and validation
• Leads efforts with manufacturing, process development, facilities, QA, and other stakeholders in developing requirements and recommendations for system implementations and modifications
• Provides oversight of Automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution
• Leads Automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA)
• Provides technical support for troubleshooting, improving, or optimizing ongoing Manufacturing, Utilities/Facilities and Process Sciences equipment and systems

• Bachelor's degree in Electrical or Chemical Engineering or related technical field
• 8-10 years of relevant work experience - including design, build, test and ongoing operations support
• Manufacturing experience, including experience managing automation projects and leading automation system design, including 24x7 manufacturing operational support
• Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
• Ability to provide rotating 24x7 on-call technical support of Automation systems for ongoing operations
• Ability to lift 50 lbs.
• Ability to travel up to 10% and Valid driver's license