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Senior Automation Integration Engineer

Regeneron
On-site
Rensselaer, NY
Operations

Role Summary

Senior Automation Systems Integration Engineer responsible for designing, implementing, and supporting data acquisition and analysis systems. Work involves real-time data collection and analysis, integrating software and hardware for automated equipment, and ensuring compliance with change control and GAMP 5 guidelines. Collaborate with a diverse team of engineers, developers, analysts, and administrators to optimize manufacturing processes.

Responsibilities

  • Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures.
  • Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automated control systems.
  • Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines.
  • Supporting small manufacturing, engineering, and validation projects.
  • Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action.
  • Authoring or updating system specifications, user and functional requirements specifications, generating and executing FAT and SAT protocols.
  • Reviewing cyber security vulnerabilities and risk pertaining to automation systems, software, and infrastructure.
  • Creation, modification, and maintenance of automation system documentation.

Skills

  • Experience with OT applications, including SCADAs, HMIs, Historians, etc.
  • Familiarity with standing up large systems at the enterprise level
  • Core knowledge of ISE S95 and S88 principles and IT/Automation integration
  • Familiarity with PLC communication, HMIs, computerized system design and maintenance of automation process control infrastructure
  • Commitment to continuous improvement and project-oriented work
  • Aim to be regarded as an expert in keeping biopharmaceutical processes running smoothly
  • Ability to balance changing priorities with increasing workload and communicate timely decisions

Qualifications

  • Bachelor's Degree in Computer Science, Chemical, Mechanical, or Electrical Engineering
  • Senior Engineer: 5+ years of relevant experience
  • Principal Engineer: 8+ years of relevant experience
  • Level will be determined based on qualifications relevant to the role

Education

  • Bachelor's Degree in Computer Science, Chemical, Mechanical, or Electrical Engineering

Additional Requirements

  • On-site work may be required in certain locations; discuss policy with recruiter/hiring manager
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