What are the responsibilities and job description for the Sr CSV Engineer position at Spark Life Solutions, Inc.?
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 :
