Automation Engineer (OT Systems)
About the role
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 ResponsibilitiesAutomation 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.
Questions about this role
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