Job Description

The Computer System Validation (CSV) Engineer II will ensure compliance of computerized systems within a pharmaceutical manufacturing environment, focusing on the development, execution, and closure of Installation, Operational, and Qualification (IOQ) protocols for critical systems like SCADA and MES.

Responsibilities

• Develop and author IOQ protocols
• Execute IOQ protocols in a cleanroom environment
• Perform data collection and deviation management
• Generate and finalize IOQ reports
• Support qualification of iFIX SCADA and MES components
• Collaborate with IT and Automation teams
• Maintain validation documentation
• Participate in risk assessments and impact analyses

Requirements

• Bachelor’s degree in Engineering, Computer Science, or related field
• 2–4 years of experience in Computer System Validation
• Hands-on experience with MES and iFIX SCADA system qualification
• Strong understanding of GAMP 5, FDA, and EU GMP guidelines
• Familiarity with cleanroom operations
• Excellent technical writing and documentation skills
• Ability to work independently

Benefits

• No benefits