CSV Lead
Katalyst CRO · Harrisburg, PA · 3 wk ago
HybridManagementContract
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+ 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.