Senior CSV Lead – Sterile Drug Validation
Katalyst CRO
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Job summary
Katalyst CRO in Lancaster, PA seeks an experienced CSV Lead to validate computer systems for a new Sterile Drug Product Clinical Manufacturing Facility, supporting the 2028 transition. Report to the Automation Lead, work with Automation Engineers to develop the CSV strategy and documentation, and lead validation execution through 2027.
The role requires independent, fast-paced work, with flexible hours to meet project delivery timelines.
Qualifications
- 10-15 years of CSV experience in pharma/biotech manufacturing.
- Experience supporting sterile manufacturing facilities.
- Independent work style with strong communication skills.
- Familiarity with cGMP and regulatory requirements.
Responsibilities
- Lead development and execution of CSV strategy and documentation.
- Support validation activities for computer systems in sterile production.
- Develop and execute CSV lifecycle documents (protocols, reports).
- Collaborate with Automation Engineers and cross-functional teams.
- Assist investigations of protocol deviations and validation issues.
- Participate in validation execution throughout the project lifecycle.
- Support testing of field I/O, instrumentation, and control systems.
Skills
Tools
Job description
Katalyst CRO in Lancaster, PA seeks an experienced CSV Lead to validate computer systems for a new Sterile Drug Product Clinical Manufacturing Facility, supporting the 2028 transition. Report to the Automation Lead, work with Automation Engineers to develop the CSV strategy and documentation, and lead validation execution through 2027.
The role requires independent, fast-paced work, with flexible hours to meet project delivery timelines.
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