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Homology Medicines, Inc. Senior Control Systems Engineer in Bedford, Massachusetts

The Senior Control Systems Engineer provides hardware and software troubleshooting and programming assistance on utility systems, manufacturing equipment, laboratory equipment and building systems in a highly regulated cGMP environment. This individual will be a part of a team to advance a fundamentally important aspect of the company’s long-term success focused on internal manufacturing capability. The Senior Control Systems Engineer is creative, team oriented, and has hands on experience in process and building automation technologies required to support a cGMP manufacturing facility.

  • Ownership and administration of equipment control systems in a cGMP regulated environment

  • Identify, lead, and support system improvements; development of detailed specifications, engineering documents, and standard operating procedures

  • Lead technical root cause analysis, incident investigations, and troubleshooting issues related to electrical, instrumentation, and equipment control systems

  • Supply information and technical data for securing spare parts

  • Provide responsive customer support with emphasis on customer satisfaction

  • Perform start up and commissioning activities as required

  • Work in a collaborative team environment and interact with other support groups such as Engineering, Facilities, Validation, Quality Assurance, IT, and Manufacturing

  • Interact and oversee work of vendors and/or contractors

  • Develop and implement preventative maintenance programs for control systems

  • Bachelor’s Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment

  • Manufacturing control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment specifically in GMP environment

  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices

  • Experience with Rockwell Automation is strongly desired (Factory Talk SE, PlantPAX, Studio 5000)

  • Experience with Johnson Controls, Data Historian (Factory Talk Historian SE, PI) and system integration of OEM equipment (OPC communication)

  • Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11

  • Experience with network architecture including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls

  • Excited about working collaboratively in a fast paced, team-based environment

Job ID: 2020-1148