Sr. Validation Engineer (CSV)

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Company: Katalyst HealthCares and Life Sciences

Location: La Verne, CA 91750

Description:

Responsibilities:

Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs).
Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements.
Provide leadership and training in validation activities.
Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP).
Ensure compliance with quality system elements for computer systems/software testing.
Perform gap assessments and remediation activities.
Investigate and resolve non-conformances, deviations, CAPAs, and change controls.
Participate in internal/external software audits.
Contribute to process improvements and documentation.

Requirements:

Bachelor's/Master's in Computer Science/Engineering.
10+ years in CSV in regulated industries (pharma, biotech, medical device).
Proficiency in SDLC, change management, validation techniques.
Experience with GAMP 5, FDA 21 CFR Part 11, EU GMP, ISO standards.
Project management and leadership experience.
Familiar with Quality Management, Document Management, and Validation Management Systems.