Automation & OT Engineer

We are looking for an Automation Engineer to develop the site's automation strategy while ensuring the day-to-day reliability, compliance, and continuous improvement of the operational technology running production equipment. Sitting at the intersection of automation engineering and IT operations, this person will lead complex projects and act as the primary technical expert for the shop floor, balancing hands-on troubleshooting of PLCs and servers with structured, GMP-compliant change management.

Key Responsibilities

• 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

Your Profile

• 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 technical proficiency in automation hardware (PLC & SCADA systems), HMI/SCADA configuration, Windows Server administration, and OT cybersecurity fundamentals

• Proven leadership experience with excellent communication skills, structured problem-solving under pressure, and a strong ownership mindset

• Deep familiarity with GMP/CSV concepts (GAMP 5, EU GMP Annex 11, 21 CFR Part 11) and modern data integration architecture

• Fluent in English (working language); German is a strong advantage