Automation Engineer

Responsibilities

• Administer and maintain Operational Technology (OT) systems, including user account management, system configurations, and version control.
• Plan, execute, and oversee automation and control system projects to ensure alignment with scope, budget, and regulatory requirements.
• Provide technical support for routine and corrective maintenance of automated systems to ensure maximum uptime and reliable performance.
• Support commissioning, validation, and qualification (IQ/OQ/PQ) activities for automated systems in compliance with GMP procedures.
• Manage lifecycle activities including upgrades, migrations, and obsolescence management in coordination with vendors and IT.
• Support site data integrity initiatives in alignment with 21 CFR Part 11 and ALCOA+ principles.
• Identify and implement hardware and software improvements to enhance system reliability and efficiency.

Requirements

• 5+ years of automation experience within a regulated manufacturing environment (FDA/USDA).
• Hands-on expertise with Rockwell Automation platforms, including ControlLogix/CompactLogix PLCs, FactoryTalk, and PanelView.
• Working knowledge of SCADA/MES platforms such as Inductive Automation Ignition and/or AVEVA Wonderware.
• Proven experience with commissioning and validation processes (IQ/OQ/PQ).
• Strong understanding of 21 CFR Part 11 compliance and data integrity standards.
• Ability to provide on-call support and perform occasional cleanroom gowning.

Preferred Qualifications

• Bachelor's degree in Chemical, Electrical, or Mechanical Engineering.
• Experience with Building Automation Systems (BAS) such as Siemens Desigo or Apogee.
• Knowledge of instrumentation and control systems, including sensors, transmitters, and loop tuning.
• Understanding of biotechnology processes and equipment.

About the Company

Syngene International provides integrated drug discovery and development services, supporting the global pharmaceutical and biotechnology industries through advanced engineering and manufacturing solutions.