Automation Engineer for GMP OT Systems (Remote/Onsite)

K-Recruiting GmbH; Lavamünd; Vor Ort; EUR 116.000 - 158.000; Vollzeit

Zusammenfassung

K-Recruiting GmbH is seeking an Automation & OT Engineer to develop the site's automation strategy and ensure reliable GMP-compliant production IT/OT operations. You will lead projects and act as the primary technical expert on the shop floor, balancing hands-on PLC/SCADA work with formal change control.

The role requires a degree in a technical field and 5+ years in industrial automation within GMP pharma, with strong knowledge of PLCs, HMIs, Windows Server, and OT security.

Qualifikationen

• Degree in Computer Science, Information Technology, Automation, Engineering, or a related technical field.
• 5+ years of hands-on industrial automation or IT experience within a GMP pharma environment, ideally with direct exposure to fill and finish operations.
• Strong proficiency in automation hardware (PLC & SCADA), HMI/SCADA configuration, Windows Server administration, and OT cybersecurity fundamentals.
• Familiarity with GMP/CSV concepts (GAMP 5, EU GMP Annex 11, 21 CFR Part 11) and modern data integration architecture.

Aufgaben

• Co-develop and support the site's overall automation strategy.
• Manage project pipelines, budgets, CAPEX/OPEX engineering tasks, and end-to-end hardware/software lifecycle planning.
• Execute daily maintenance and troubleshooting for automation hardware (HMIs, PLCs).
• Administer underlying IT infrastructure where applicable, including Windows Servers, OS patching, OT network segmentation, and cybersecurity hygiene.
• Oversee automation systems for critical fill and finish operations, including filling lines, isolators, freeze dryers, autoclaves, and building utilities.
• Ensure strict adherence to cGMP, Data Integrity, and CSV regulations.
• Draft and update technical documentation, execute rigorous change control, and support validation activities.
• Maintain and regularly test backup/restore and disaster recovery procedures to ensure uptime and validated state of all production equipment.
• Partner with manufacturing, QA, and maintenance teams to optimize systems.
• Manage vendor SLAs, maintain spare parts inventory, and provide on-call support for critical system alarms.

Kenntnisse

PLC & SCADA

HMI/SCADA

Windows Server

OT cybersecurity

Leadership

Communication

Ausbildung

Degree in Computer Science/IT/Automation/Engineering

Jobbeschreibung

K-Recruiting GmbH is seeking an Automation & OT Engineer to develop the site's automation strategy and ensure reliable GMP-compliant production IT/OT operations. You will lead projects and act as the primary technical expert on the shop floor, balancing hands-on PLC/SCADA work with formal change control.

The role requires a degree in a technical field and 5+ years in industrial automation within GMP pharma, with strong knowledge of PLCs, HMIs, Windows Server, and OT security.