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Capgemini

Lead Manufacturing Automation Engineer - Pharmaceutical Manufacturing

1w

Capgemini

Chicago, US · Full-time · $125,000 – $166,000

About this role

Join Capgemini as a Lead Pharmaceutical Manufacturing Automation Engineer to lead and support the design, implementation, validation, and maintenance of automation and OT systems across site operations and projects. Ensure system reliability, regulatory compliance, and effective integration of automation platforms with manufacturing processes across multiple US locations. Contribute to solution design, troubleshooting, continuous improvement, and documentation.

Deploy DCS/SCADA/PLC recipes and control logic, configure and maintain Historian, and manage software change controls to meet manufacturing needs. Lead troubleshooting, provide project technical guidance, and execute engineering tests, changes, and documentation per quality standards. Drive site automation rollout considering cost, schedule, and technical aspects.

Operate and maintain OT systems/tools/apps, support OT owners, and monitor IT/OT events while tracking and auditing configuration items. Execute OT and cybersecurity processes and maintain OT asset inventory. While the role can be remote, travel between sites is required approximately 50% of the time to Indiana, New Jersey, and California manufacturing sites.

Perform GMP risk assessments including SRA, create/execute DQ/IQ/OQ, and troubleshoot during PQ and validation. The ideal candidate will be situated in a major metro area in or near these states. At Capgemini, shape your career with support from a collaborative global community and reimagine what's possible.

Requirements

  • 7+ years of experience in pharmaceutical, biotech, or medical device manufacturing environments
  • Demonstrable experience with automation engineering, OT engineering, or related disciplines
  • Experience with automation systems including PLCs, SCADA, DCS, HMIs, or control networks
  • Experience with regulatory frameworks related to Computerized System Validation (CSV) and Data Integrity (DI)
  • Familiarity with CSV and Data Integrity requirements in GxP-regulated environments
  • Hands-on experience with troubleshooting automation systems, implementing changes, and creating technical documentation
  • Understanding of OT systems, cybersecurity

Responsibilities

  • Support automation/network technical requests
  • Execute change controls and work orders
  • Deploy DCS/SCADA/PLC recipes and control logic
  • Configure and maintain Historian
  • Manage software change controls
  • Lead troubleshooting and project technical guidance
  • Operate and maintain OT systems/tools/apps
  • Perform GMP risk assessments including SRA

Benefits

  • Remote role with approximately 50% travel to manufacturing sites in Indiana, New Jersey, and California
  • Empowered to shape your career in the way you’d like
  • Supported and inspired by a collaborative community of colleagues around the world