What are the responsibilities and job description for the Computer System Validation Engineer position at Spark Life Solutions Inc?
Job Description
Job Description
Roles & Responsibilities :
- Ensure all qualified and validated equipment / systems comply with company policies, guidelines, and procedures.
- Develop and execute equipment qualification and validation protocols, supporting calibration and validation activities.
- Configure, document, and manage the lifecycle of computerized systems, ensuring compliance with CSV requirements.
- Create validation documentation, including Validation Plans, User Requirement Specifications, Traceability Matrices, Summary Reports, and Change Controls.
- Oversee laboratory and manufacturing equipment implementation projects, managing timelines, procurement, installation, qualification, and turnover.
- Independently manage qualification and CSV activities for single and multi-user systems.
- Supervise vendors performing qualification activities, ensuring compliance with regulatory and company standards.
- Provide technical support on calibration, equipment procurement, maintenance, and lifecycle management.
- Maintain accurate and precise validation documentation in line with company and regulatory standards.
- Respond to qualification and support requests promptly, maintaining strong client relationships and fostering a collaborative team environment.
Education & Experience :
