Responsible for project leadership and daily support of the Manufacturing, Utilities and Building control systems at the Norton, MA facility. 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 Manufacturing, Quality, Process Engineering, Validation and other applicable stakeholders. Additional cross-site collaboration and support may be required for Cambridgelocations, Kendall Square and Alewife. Summary of Key Responsibilities
- Lead the planning and execution of Automation systems being implemented at Norton, MA Greenfield 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.
- Provide Subject Matter Expertise 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, Utilities/Facilities and Process Sciences equipment and systems.
- To support all Automation related activities at Alnylam Alewife and Norton manufacturing sites, as well as Process Sciences labs in Kendall Square, Cambridge MA.
- Provide System Ownership of Automation systems, ensuring compliance with Standard Operating Procedures and cGMPs.
- Responsible for the development and maintenance of lifecycle deliverables for Automation systems.
- Act as technical advisor on instrumentation and controls issues, and mentor junior engineers.
- Perform other duties as needed
- Requires a 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.
- Experience with translation of user requirements into Automation design, specifically technology transfer, process and equipment solutions.
- 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 experienceworking with Rockwell Automation (PlantPAx) in project execution and lifecycle management.
- Hands on experience with Delta Controls Building Management, Intellution iFix and GE Unicorn a plus.
- 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 10%
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.