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Manager, Engineering Systems

Manager, EngineeringSystems
Overview
Alnylam was founded in 2002 on arevolutionary vision and bold mission which remain firmly in place today. Weare leading the translation of RNA interference (RNAi) into a new class ofinnovative medicines with the potential to transform the lives of people withrare genetic, cardio-metabolic, hepatic infectious, and central nervous systemdiseases 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 thepolyneuropathy of hereditary transthyretin-mediated amyloidosis in adults andby the European Medicines Agency in the EU for the treatment of hATTRamyloidosis 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 beenrecognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017and 2018- four years in a row!
Responsible fordefining and leading Engineering Systems at Alnylam Pharmaceuticals. Implement and own processes as the newgreenfield manufacturing facility currently under construction in Norton, MA isbrought on-line as well as the 665 Concord Ave, Cambridge site (Alewife) andcorporate headquarters in Kendall Square Cambridge, MA. Engineering systems to include, but notlimited to; drawing management, turnover package (TOP), and Engineering ChangeManagement programs. Act as liaison withall Facilities and Engineering teams to ensure good engineering practices, andturnover packages meet Alnylam requirements.
Summary of Key Responsibilities
Work in cross-functional teams to define robust, efficientengineering programs required for executing projects and ongoingoperational/maintenance activities for GMP and non-GMP sites.
Own drawing management program, defining procedures/processas well as any tools/techniques and managing workload across the Facilities andEngineering department.
Manage external service providers, such as Revit or AutoCADfile update required for project changes for medium to large changes. Execute small changes internally, asapplicable.
Own Engineering change management program, definingworkflows, forms/processes and database administration.
Own turnover package acceptance from vendors, as well aslifecycle management of changes, including tools/techniques required.
Provide project support for vendors for all engineeringdeliverables to ensure consistency and alignment with Alnylam standards.
Act as liaison for project teams across the company to ensureconsistent approach to documentation produced by various Architectural andEngineering firms.
Work closely with all areas of Facilities and Engineeringteam to ensure good engineering practices and standards are updated andimproved over as needed.
Qualifications
Experience implementing programs forcontinuous improvement by leveraging system performance data and industry bestpractices
Direct experience with good engineeringpractices, specifically in regulated environments (i.e. cGMP, OSHA, NFPA70,EPA). Detailed understanding of cGMPprocesses; commissioning and qualification, validation, change controlpreferred
Working knowledge of Revit 3D modelling andAutoCAD drawing tools.
Excellent organizational, verbal and writtencommunication skills and be able to efficiently communicate withcross-functional teams and management on recommended course of action, withminimal assistance
The ability to work at all AlnylamMassachusetts site locations/facilities.
Carry a mobile phone/ device
Valid driver's license
Ability to provide rotating 24x7 on-calltechnical support of Automation systems for ongoing operations
Ability to lift 50 lbs.
Ability to travel up to 10%
Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.


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