Computer System Validation Lead

Position Overview

The position supports the Validation of Computer systems in support of a newly constructed Sterile Drug Product Clinical Manufacturing facility. It serves a key role in delivering to accommodate the exit of the existing facility in 2028. The role has a hybrid/flexible work structure from 2026, transitioning to a majority on-site presence starting January 2027.

Key Responsibilities

• Lead and support the development of the CSV approach, aligned with company policies, and independent of the existing commercial organization.
• Develop and execute CSV documents.
• Extend into the execution phase of validation through 2027.
• Work independently with ~10-15 years of experience and flexibility to accommodate project delivery schedules.
• Resolve technical protocol deviations within the R&D project team using communication skills.

Technical Skills

• Alignment with existing Automation solutions: Particle and Equipment.
• Monitoring, Alarm Management Systems.
• AVEVA System Platform.
• Allen Bradley and Siemens PLC.
• AVEVA Pi Historian.
• Understanding of Operational Technology concepts.
• Hands-on experience in testing of field I/O, instrumentation, and control systems.
• Experience with SCADA, HMI, and Client platforms, communications, and network infrastructure.
• Independent control platforms to support Robotic isolator and filling line, capable of supporting multiple dose forms with unique capabilities (Lyophilization).
• Independent control platforms to support Formulation and Wash Isolators.
• Independent control platforms to support Autoclave and Equipment Wash areas.
• PLC of Door Interlocking system.