SCADA Automation control Engineer

Automation Controls Engineer

Role Summary

Hands-on Automation Controls Engineer responsible for the day-to-day operational technology (OT) control layer on the shop floor, including PLC, SCADA, and HMI systems across Drug Substance (DS) and Drug Product (DP) process areas.

The role will work under the Sweden Engineering and Automation Head, supporting the installation, commissioning, troubleshooting, and ongoing reliability of process equipment within a GMP-regulated manufacturing environment.

Key Responsibilities

1. PLC, SCADA & HMI Engineering

• Configure, test, and maintain PLC and SCADA systems for process skids, utilities, and packaging lines.
• Work with Siemens TIA Portal, Rockwell Studio 5000, or equivalent platforms.
• Perform ladder/structured-text logic changes, I/O commissioning, loop tuning, and HMI screen updates.
• Execute changes in accordance with formal change-control processes.

2. Installation & Commissioning

• Support the installation and commissioning of new process equipment.
• Participate in FAT/SAT (Factory Acceptance Testing/Site Acceptance Testing).
• Write and execute IQ/OQ (Installation Qualification/Operational Qualification) test scripts.
• Verify instrumentation and field wiring.
• Work with system integrators and site engineering teams to bring equipment to a validated, production-ready state.

3. Shop-Floor Automation Support

• Provide first-line automation support for manufacturing operations.
• Troubleshoot control faults, alarms, and interlocks.
• Work with operators and maintenance teams to identify and resolve automation-related issues.
• Conduct root-cause investigations for automation-related deviations.
• Document troubleshooting activities, corrective actions, and fixes in accordance with the quality system.

4. OT Data & Connectivity

• Maintain plant OT data and connectivity infrastructure.
• Support historian tags, OPC UA/Modbus connections, and SCADA-to-L2/MES/batch interfaces.
• Ensure reliable flow of batch records and process data.
• Support the foundational OT architecture required for future IIoT and analytics initiatives.

5. OT Compliance, Reliability & Cybersecurity

• Maintain backups, software versions, and user access for controllers and OT servers.
• Ensure systems are maintained in line with GAMP 5 and 21 CFR Part 11 requirements.
• Follow basic OT cybersecurity practices, including IEC 62443 principles and network segregation.
• Monitor hardware obsolescence and contribute to the site's automation and OT upgrade plans.

Required Skills & Experience

• Hands-on experience in industrial automation and controls engineering.
• Strong experience with PLC, SCADA, and HMI systems.
• Experience with Siemens TIA Portal and/or Rockwell Studio 5000.
• Experience with PLC programming, I/O commissioning, instrumentation, and control systems troubleshooting.
• Experience with FAT/SAT and IQ/OQ in a regulated manufacturing environment.
• Experience working in GMP/GxP environments, preferably within pharmaceutical or life sciences manufacturing.
• Knowledge of SCADA, historians, OPC UA/Modbus, MES, and batch interfaces.
• Understanding of GAMP 5, 21 CFR Part 11, and OT cybersecurity principles.
• Strong troubleshooting, root-cause analysis, documentation, and stakeholder communication skills.