Computer Systems Validation (CSV) Engineer

Responsibilities

• Develop and implement strategies for the validation of computer systems in compliance with domestic and international regulations.
• Prepare and maintain all necessary validation documents, including validation master plans, validation plans, and risk assessments.
• Execute validation protocols and prepare validation summary reports.
• Manage change control for validated systems and perform impact assessments for changes to validated systems.
• Conduct training on CSV principles and procedures.
• Ensure compliance with all relevant regulations, including GxP, GAMP5, ERES, and Data Integrity.
• Collaborate with cross-functional teams to ensure smooth execution of validation activities.

Requirements

• Experience in a CSV role within the pharmaceutical industry is a MUST.
• Strong knowledge of GMP, GAMP5, ERES, and Data Integrity.
• Excellent communication and organizational skills.