We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
Your missionWe are looking for a Senior Automation & OT Engineer to develop our automation strategy while ensuring the day-to-day reliability, compliance, and continuous improvement of the operational technology running our production equipment.
Sitting at the intersection of automation engineering and IT operations, you will lead complex projects and act as the primary technical expert for the shop floor.
You will balance hands-on troubleshooting of PLCs and servers with structured, GMP-compliant change management to support safe, efficient manufacturing.
Key ResponsibilitiesStrategy & Leadership: Co - develop and support the site's overall automation strategy.
Systems Operations & IT: Execute daily maintenance and troubleshooting for automation hardware (HMIs, PLCs).
Administer if applicable underlying IT infrastructure, including Windows Servers, OS patching, OT network segmentation, and cybersecurity hygiene.
Process Equipment Expertise: Oversee automation systems for critical fill and finish operations, including filling lines, isolators, freeze dryers, autoclaves and building utilities.
GMP & CSV Compliance: Ensure strict adherence to cGMP, Data Integrity, and CSV regulations.
Draft and update technical documentation, execute rigorous change control, and support validation activities.
Disaster Recovery: Maintain and regularly test backup/restore and disaster recovery procedures to ensure the uptime and validated state of all production equipment.
Cross-Functional Collaboration: Partner with manufacturing, QA, and maintenance teams.