Control Engineer

6 days ago

Boston, United States fortil Full time

Founded in 2009, the Fortil group was created by entrepreneurial engineers.

We operate in sectors such as: automotive, railways, aeronautics, IT, Naval, Life Science.

Today, Fortil represents: some 2,000 employees for over 500 industrial partners, a presence as close as possible to our customers and employees in Europe, North America.

We are looking for a Senior Control Engineer

  • Provide technical leadership for the designated area and system(s) to ensure a compliant and reliable product supply, as well as timely project execution.
  • Offer production shop floor support when necessary.
  • Apply effective project management techniques to meet schedule, budget, benefit realization, and other project objectives.
  • Provide technical guidance and support, including reviewing and approving system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other automation-related processes.
  • Support regulatory inspections and audits by serving as a subject matter expert.
  • Ensure compliance with GMPs, safety, and environmental regulations.
  • Review automation documents, preventive maintenance, and SOPs periodically to ensure compliance.
  • Assist in the development, review, and approval of department SOPs and site GMP SOPs related to automation and digital activities.
  • Develop and support corrective actions for automation-related deviations/investigations.
  • Provide updates to immediate supervisor on area of responsibility.
  • Collaborate across Operations, Quality, and Technical teams to solve complex problems.
  • Use technical expertise to ensure efficient operation of automated processing and information technology systems.
  • Install new equipment and develop solutions for automation issues.
  • Identify and implement process/equipment improvements and manufacturing efficiencies.
  • Responsible for specific Fermentation control systems related to Seed and Production Fermentors and supporting equipment, ensuring compliance with SLC, GMP, Data integrity, safety, and environmental regulations.

About you

Minimum of five (5) years of experience in a regulated production industry. Minimum of five (5) years of experience in a role related to GMP manufacturing automation, with direct experience in SDLC and change controls. Direct experience with at least two of the following platforms: 1) Emerson DeltaV, 2) Allen Bradley PLC (or equivalent), and 3) PI (or equivalent).

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