Automation Engineer III

## Automation Engineer IIIUnited States Apply Now Find out how well you match with this jobJob ID3092

This role is considered:

On-Site
** Overview
* * 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.

This is an onsite role based primarily at the Cambridge, MA facilities.
** Key Responsibilities
*** Support all Automation related activities at Alnylam Process Sciences labs in Kendall Square, Cambridge MA as well as Alewife and Norton manufacturing sites
* Lead and/or support the planning and execution of Automation systems being implemented at Kendall Square, Cambridge, MA facilities
* Apply advanced Automation engineering principles to the design and implementation of system modifications, experiments and/or capital projects; develop, organize, analyze and present 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
* 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
* Promote a culture of safe and compliant design and operation
* Lead efforts with key stakeholders in developing requirements and recommendations for Automation system implementations and modifications
* Provide oversight and technical assistance of Automation system service providers, contract resources and Instrument/Electrical technicians
* 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.
* 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.
** Qualifications
* ** Requires a Bachelor’s degree in Electrical or Chemical Engineering or related technical field.
* 4-8 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. 21

CFR Part 11, EU Annex 11)
* Demonstrated experience…