CSV Lead: Sterile Drug Validation & Automation

Katalyst CRO; Lancaster (Lancaster County); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced automation validation professional to lead the CSV strategy for a new Sterile Drug Product Clinical Manufacturing facility in the US. The role will focus on developing and executing CSV documents, coordinating with the Automation team, and ensuring compliance with company policies while supporting the exit of the current facility.

With 10–15 years of hands-on experience and a strong ability to work independently, you will adapt to a hybrid/flexible work

Qualifications

• 10–15 years of hands-on automation/validation experience.
• Ability to work independently on complex validation projects.
• Strong communication to resolve technical deviations within R&D teams.

Responsibilities

• Lead and support development of CSV strategy for new sterile manufacturing facility.
• Develop and execute CSV documentation.
• Support validation execution through 2027 and adapt to project needs.

Skills

CSV validation leadership

Independent work

Technical communication

Tools

AVEVA System Platform

Allen-Bradley PLC

Siemens PLC

AVEVA Pi Historian

SCADA/HMI

Kneat

Job description

Katalyst CRO seeks an experienced automation validation professional to lead the CSV strategy for a new Sterile Drug Product Clinical Manufacturing facility in the US. The role will focus on developing and executing CSV documents, coordinating with the Automation team, and ensuring compliance with company policies while supporting the exit of the current facility.

With 10–15 years of hands-on experience and a strong ability to work independently, you will adapt to a hybrid/flexible work