CSV Validation Engineer

Job Summary

Seeking an experienced CSV Validation Engineer for a full-time remote position, responsible for leading the implementation of risk-based validation strategies, supporting GxP validations, and developing a scalable validation framework for various systems.

Key Responsibilities:

• Lead the development and implementation of a risk-based validation approach in accordance with CSA principles and regulatory guidelines
• Define and maintain validation strategies for both GxP and non-GxP systems, including authoring core validation deliverables
• Collaborate with cross-functional teams to integrate risk-based validation practices into project lifecycles and provide training on validation requirements

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Information Technology, or a related field
• 4-8 years of experience in system validation within life sciences, medical device, pharmaceutical, or biotech industries
• Deep understanding of CSA methodologies, risk-based validation practices, and GAMP 5 guidelines
• Strong working knowledge of regulatory requirements for GxP systems (21 CFR Part 11, Annex 11)
• Practical experience implementing and validating non-GxP systems in a structured, compliant environment