CSV Engineer

We are looking for a CSV Engineer to execute and review the activities in compliance with the company CSV program; the designated person shall have the self-driven approach in the capacity of computer system validations & associated areas.

Key Responsibilities:

• Preparation, execution and reporting of GxP computerized systems validation deliverables at site.
• Ensure all validation activities adhere to regulatory requirements and company standards.
• Ensure compliance of all GxP computerized systems validation activities at the site.
• Maintain the validated state of all GxP computerized systems used at the site.
• Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
• Ensure self-inspection and remediation activities related to GxP computerized systems.
• Conduct periodic reviews of all GxP computerized systems at the site to ensure continued compliance.
• Provide inputs for the revision and implementation of Computerized System Validation (CSV) procedures.
• Manage associated QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs.
• Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance.
• Ensure the site is prepared for all audits and actively participate during audit processes.
• Provide training to cross-functional team (CFT) members on CSV-related procedures.

Skills, Attributes & Experience:

• Bachelor's degree in Computer Science, Information Technology, Engineering or a related field with 4 -6 years of experience.
• Strong knowledge of regulatory requirements and industry standards for GxP computerized systems.
• Demonstrated ability to drive compliance through delivery of CSV activities.