CSV Lead: Life Sciences Software Validation & Compliance

Kriya Therapeutics, Inc.; Milwaukee (WI); Vor Ort; USD 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Flexible Time Off

Health Insurance

401(k) with Company Match

Zusammenfassung

Kriya Therapeutics, Inc. in Research Triangle Park, NC seeks a Manager, Computer Software Assurance & Validation to lead the CSV program and set validation strategy across computerized systems.

The role ensures regulatory compliance, drives continuous improvement, and collaborates with Business Owners, Quality, Automation, Manufacturing and Facilities to validate GMP-related systems and maintain validated states.

Qualifikationen

• Bachelor’s degree in engineering or life sciences.
• 7+ years of CSV experience in cGMP pharma/biopharma.
• Deep knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820), GAMP 5, and CSA.
• Experience validating domain- and process-controlled systems, building monitoring/alarms, historians, and test automation tools/frameworks.
• Strong data integrity knowledge (MHRA/PIC/S guidance).

Aufgaben

• Lead the CSV program and drive continuous improvement.
• Apply risk-based CSV approaches per GAMP 5 and CSA.
• Oversee validation documentation and change control activities.
• Ensure data integrity and regulatory compliance across systems.
• Collaborate with cross-functional teams to enable on-time system go-lives.

Kenntnisse

Leadership

Communication

Time management

CSV program management

Ausbildung

Bachelor’s degree in engineering or life sciences

Tools

Test automation tools

Jobbeschreibung

Kriya Therapeutics, Inc. in Research Triangle Park, NC seeks a Manager, Computer Software Assurance & Validation to lead the CSV program and set validation strategy across computerized systems.

The role ensures regulatory compliance, drives continuous improvement, and collaborates with Business Owners, Quality, Automation, Manufacturing and Facilities to validate GMP-related systems and maintain validated states.