Principal Automation Engineer
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, and 2017.
Responsible for leading Process Automation System (PAS) implementation at new, Greenfield facility in Norton, MA. Work with cross-functional teams on developing system requirements, managing System Integrator project to implement and test, and oversight of all Commissioning and Qualification needs during facility startup. Assist in overall Alnylam company standards and capital planning around Instrumentation and Controls projects.
Summary of Key Responsibilities
Lead the planning and execution of Automation systems being implemented at Norton, MA Greenfield facility.
Develop process and building automation system strategic plans for 3-5 year capital investments, across all Alnylam sites.
Provide technical leadership for capital projects, including automation system design, control system hardware, equipment design, control panel design, and instrumentation start-up and troubleshooting
Develop company automation capabilities, including development of technical standards, guidelines, and procedures in accordance with industry best practices for executing large capital projects
Support manufacturing operations, including troubleshooting of operational issues in manufacturing, maintenance, validation, or capital projects
Promote a culture of safe and compliant design and operation Serve as technical process automation leader for large capital projects, interfacing with Alnylam stakeholders and external consultants / contractors
Review and critique process and automation system designs and support project lifecycle activities in alignment with an ASTM E2500 model
Manage all aspects of automation system design and integration, including specification development, integration, and validation
Lead efforts with manufacturing, process development, facilities, QA, and other stakeholders in developing requirements and recommendations for system implementations and modifications
Provide oversight of Automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution
Lead Automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA)
Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations
Requires a Bachelor’s degree in Electrical or Chemical Engineering or related technical field
12+ 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
Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
Experience developing and executing bid activities such as requests for proposals, including scope of work identification, technical bid package development, bid evaluation and selection
Direct experience with good engineering practices, specifically in regulated environments (i.e. cGMP, OSHA, EPA). Detailed understanding of cGMP processes; commissioning and qualification, validation, change control preferred
Ability to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (i.e. 21CFR Part 11, EU Annex 11)
Demonstrated experience working with Rockwell Automation (PlantPAx) and Control Logix PLCs in project execution and lifecycle management
Familiarity with virtual infrastructure using VMware and understanding the integration between virtual and physical systems
The ability to work at all Alnylam Massachusetts site locations/facilities.
Carry a mobile phone/ device
Valid driver’s license
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 15%
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.