Sr CSV Engineer - Spark Life Solutions Inc
Santa Monica, CA 75074
About the Job
Roles & Responsibilities:
- Perform validation activities for new lab systems or system upgrades, ensuring compliance with applicable regulations and standards.
- Conduct quarterly audits of laboratory systems to maintain their validated state, including audit trail reviews and periodic system assessments.
- Manage light system administration duties, such as granting user access and maintaining user accounts.
- Ensure proper documentation and reporting of validation activities, audit findings, and system access changes.
- Collaborate with cross-functional teams including IT, lab personnel, and quality assurance to ensure the smooth operation and compliance of lab systems.
- Assist in developing validation protocols, test scripts, and reports for various lab equipment.
- Stay current with regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11) and implement best practices for CSV in a lab environment.
Education & Experience:
- Minimum 8-12 years of experience in Computer System Validation, preferably in a laboratory or life sciences setting.
- Experience in CSV for lab systems, including system upgrades and new installations.
- Knowledge of GxP regulations, 21 CFR Part 11 compliance, and validation lifecycle.
- Strong understanding of laboratory equipment and systems used in Cell therapy.
- Ability to conduct quarterly system audits and manage system administration tasks efficiently.
- Excellent communication and documentation skills to work effectively in a team-oriented environment.
Source : Spark Life Solutions Inc
