Computerized Systems Validation Specialist

Smartedge’s Client is looking for an individual to help with their Computer System Validation (CSV) Engineer / CSV Engineer (Endosafe Automation) _ Contract _ EU (Remote)

Job Details:

Role : 1

Role: Computer System Validation (CSV) Engineer

Role Location: EU (Remote)

Role Type : Contract

Job description:

· Validation of AI models and related automation platforms used for technical information management.

· Ensure compliance with applicable EU regulatory requirements.

· Support validation documentation and

· execution activities.

· Assist with post-deployment validation support and issue resolution.

· Strong knowledge of EU regulatory requirements.

· Experience in Computer System Validation (CSV).

· Minimum 5+ years of relevant experience.

· Experience with AI/automation validation environments preferred.

· Strong life sciences/pharmaceutical/manufacturing validation experience preferred.

· Relevant validation experience (FDA, Part 11, EU regulations, MES, Automation Systems, AI validation, etc.)

2. Role: CSV Engineer (Endosafe Automation)

Role Location: EU (Remote)

Role Type : Contract

Job description:

· Work with automation equipment vendors to understand software functionality and capabilities.

· Validate integration with enterprise systems, including MES and reporting platforms.

· Coordinate validation activities with Quality teams.

· Support post-launch validation and operational issues.

· Validation to FDA standards.

· FDA 21 CFR Part 11 compliance experience.

· Strong Computer System Validation (CSV) background.

· Minimum 5+ years of relevant experience.

· Strong life sciences/pharmaceutical/manufacturing validation experience preferred.

· Relevant validation experience (FDA, Part 11, EU regulations, MES, Automation Systems, AI validation, etc.).

 If this sounds like a role you would be interested in or if you know someone in this field.

Connect with me or email me at [email protected]

Alternatively, you can call me on Tel:+44(0)2035002387