Computer System Validation engineer

Summary :

As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations.

Roles & Responsibilities:

• Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports.
• Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.
• Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.
• Provide training to stakeholders on validation requirements and best practices.
• Maintain validation lifecycle documentation and change control records.

Education & Experience:

• Experience with CSV in a regulated pharmaceutical or biotech environment.
• Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11.
• Proficiency in authoring and executing validation documentation.