CSV Lead — Sterile Drug Manufacturing Validation

Katalyst CRO; Harrisburg (Dauphin County); On-site; USD 140,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced CSV Lead to validate computer systems for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. The role reports to the Automation Lead and works with Automation Engineers on facility and equipment system design, guiding CSV approach and alignment with company policies, independent from the commercial organization.

The candidate will lead development and execution of CSV documentation, and support validation activities through 2027 in a

Qualifications

• 10-15 years 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.

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.
• Ensure compliance with cGMP and regulatory requirements

Skills

Independent work

Strong communication

Troubleshooting

Cross-functional collaboration

Project management

Tools

AVEVA System Platform

Allen Bradley PLC

Siemens PLC

AVEVA PI Historian

Alarm Management Systems

OT concepts

SCADA/HMI/Client platforms

Networking infrastructure

Robotic Isolator

Lyophilization

Formulation and Wash Isolators

Autoclave and Equipment Wash

Door Interlocking PLC systems

Kneat

Job description

Katalyst CRO seeks an experienced CSV Lead to validate computer systems for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. The role reports to the Automation Lead and works with Automation Engineers on facility and equipment system design, guiding CSV approach and alignment with company policies, independent from the commercial organization.

The candidate will lead development and execution of CSV documentation, and support validation activities through 2027 in a