CSV Lead

Responsibilities

• Lead development and execution of CSV strategy and documentation.
• Support validation activities for computer systems associated with sterile drug product manufacturing.
• Develop and execute CSV lifecycle documents including protocols and reports.
• Collaborate with Automation Engineers and cross-functional project teams.
• Support investigation and resolution of technical protocol deviations.
• Participate in validation execution activities throughout the project lifecycle.
• Support testing activities related to field I/O, instrumentation, and control systems.

Requirements

• 10-15 years of Computer System Validation (CSV) experience.
• Strong pharmaceutical or biotech manufacturing experience.
• Experience supporting sterile manufacturing facilities preferred.
• Ability to work independently with minimal supervision.
• Strong communication and troubleshooting skills.
• Experience supporting large capital projects preferred.

Technical Skills

• AVEVA System Platform.
• Allen Bradley PLC.
• Siemens PLC.
• AVEVA PI Historian.
• Alarm Management Systems.
• Particle and Equipment Monitoring Systems.
• Understanding of Operational Technology (OT) concepts.
• Hands-on experience supporting testing of field I/O, instrumentation, and control systems.
• Experience with SCADA, HMI, and Client platforms.
• Experience with communications and network infrastructure.
• Experience supporting Robotic Isolator and Filling Line systems.
• Experience supporting Lyophilization processes.
• Experience supporting Autoclave and Equipment Wash systems.
• Experience with Door Interlocking PLC systems.