Automation Engineer (OT Systems)

Position Overview

The Automation Engineer is responsible for the deployment, operation, support, and qualification of Operational Technology (OT) systems used within pharmaceutical manufacturing environments. The role supports project execution through automation implementation, system commissioning, troubleshooting, qualification support, and lifecycle management of OT infrastructure.

The Automation Engineer serves as the technical subject matter expert for automation systems and works closely with engineering, quality, validation, and operational teams to ensure reliable and compliant system performance.

Key Responsibilities
Automation System Deployment

• Lead deployment and implementation of automation hardware and software solutions.
• Manage change controls associated with automation system modifications.
• Coordinate installation, commissioning, and startup activities.
• Support system integration and site acceptance activities.

Operational Technology Management

• Manage operational technology (OT) systems, applications, and infrastructure.
• Ensure system availability, stability, integrity, and cybersecurity compliance.
• Monitor system performance and proactively address technical issues.

Qualification & Validation Support

• Support qualification activities throughout the project lifecycle.
• Develop and review:
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Design Specifications
• Test Protocols
• Qualification Documentation
• Execute qualification and validation testing activities.
• Support IQ, OQ, and PQ execution.

Troubleshooting & Technical Support

• Investigate and resolve automation-related defects and deviations.
• Perform root cause analysis and implement corrective actions.
• Support commissioning and qualification teams during issue resolution.

Risk Management & Compliance

• Perform system risk assessments and identify mitigation actions.
• Ensure compliance with GMP, GAMP5, Data Integrity, and site procedures.
• Maintain complete and audit-ready technical documentation.

Stakeholder & Project Support

• Collaborate with engineering, validation, QA, operations, and external suppliers.
• Provide technical expertise during project planning and execution.
• Support project reporting and technical decision-making.

Requirements
Required Qualifications

• Bachelor's or Master's degree in Automation Engineering, Electrical Engineering, Computer Engineering, Industrial Engineering, or a related discipline.
• Minimum 5 years of experience in industrial automation within pharmaceutical, biotech, or regulated manufacturing environments.
• Hands-on experience with automation platforms such as:
• Siemens PCS7 / TIA Portal
• Rockwell Automation
• DeltaV
• SCADA Systems
• MES Interfaces
• Strong understanding of GMP, GAMP5, qualification, and validation processes.
• Experience with commissioning, troubleshooting, and lifecycle management of OT systems.
• Fluent English required. German or French language skills are considered an advantage depending on location.

Preferred Experience

• Experience in radioligand therapy (RLT), pharmaceutical manufacturing, or sterile production facilities.
• Knowledge of OT cybersecurity requirements.
• Experience working within multinational project environments.