Job Title: CSV Lead
Location: Lancaster, PA
Job Type: Contract
🔹 Position Overview
We are seeking an experienced CSV Lead to support Computer System Validation (CSV) activities for a newly constructed Sterile Drug Product Clinical Manufacturing facility. The ideal candidate will have strong experience in CSV lifecycle management, automation systems validation, SCADA/HMI platforms, PLC systems, and pharmaceutical manufacturing environments.
This role will support the transition from the existing Sterile Drug Product Clinical Manufacturing facility and play a key role in validation activities through 2027. The position will initially follow a hybrid work structure in 2026 and transition to a majority onsite role beginning January 2027.
🔹 Key Responsibilities
- Lead the development and execution of CSV strategies and validation approaches
- Develop, review, and execute CSV lifecycle documentation including:
- URS
- Risk Assessments
- IQ/OQ/PQ Protocols
- RTM
- Validation Summary Reports
- Support automation and control system validation activities
- Collaborate with Automation Engineers and project teams to support qualification and startup activities
- Support testing of instrumentation, field I/O, SCADA, HMI, and control systems
- Resolve protocol deviations and support CAPA activities
- Ensure compliance with GAMP5, FDA, and 21 CFR Part 11 requirements
- Coordinate validation execution activities to meet project delivery schedules
- Support validation activities for sterile manufacturing equipment and control systems
🔹 Required Skills
- 10–15 years of Computer System Validation (CSV) experience
- Strong experience in pharmaceutical or sterile manufacturing environments
- Hands-on experience with:
✔ AVEVA System Platform
✔ Allen Bradley PLC
✔ Siemens PLC
✔ AVEVA PI Historian
✔ SCADA / HMI / OIT Platforms
✔ Instrumentation & Field I/O Testing
✔ Alarm Management & Equipment Monitoring Systems
✔ Operational Technology (OT) concepts - Experience supporting:
✔ Robotic Isolators
✔ Filling Lines
✔ Lyophilization Systems
✔ Autoclaves
✔ Equipment Wash Systems - Strong troubleshooting and communication skills
- Ability to work independently in fast-paced project environments
- Kneat experience preferred
🔹 Preferred Qualifications
- Experience in sterile drug product manufacturing environments
- Knowledge of GMP, GAMP5, and FDA validation standards
- Experience supporting automation-driven manufacturing systems
- Strong documentation and deviation management skills
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