CSV (Computer System Validation) Engineer / Expert

Company: GAXP

Location: Remote

Availability: Immediate Start

GAXP is seeking highly motivated Junior and Senior Computer System Validation (CSV) Experts to join our team on a full remote basis. This is an excellent opportunity to contribute to the validation of critical IT systems in regulated industries, working in a dynamic and flexible environment.

As a CSV Expert, you will be responsible for:

• Drafting and/or reviewing validation documentation across the full V-cycle, from User Requirements Specifications (URS) to the Validation Report (VR).
• Providing expert guidance on validation strategies for various IT systems, including but not limited to ERP systems, ETL tools, AI applications, and other enterprise technologies.
• Ensuring compliance with GxP regulations, industry standards (GAMP 5, FDA 21 CFR Part 11, EU Annex 11), and company validation policies.
• Collaborating with cross-functional teams to support validation efforts and risk assessments.
• Contributing to continuous improvement initiatives related to CSV processes and regulatory compliance.

• Proven experience in Computer System Validation (CSV), preferably in regulated industries such as pharmaceuticals, biotechnology, or healthcare.
• Strong knowledge of validation methodologies and GxP requirements.
• Ability to work independently in a flexible remote environment.
• Excellent English verbal and written communication skills (mandatory).
• Strong analytical mindset with great attention to detail.
• A high level of adaptability and a strong human touch, fostering collaboration and teamwork.

• Fully remote work with flexible hours.
• Opportunity to work on cutting-edge IT systems in a highly regulated industry.
• A supportive and dynamic environment that values expertise and collaboration.

If you are passionate about CSV, compliance, and technology and are looking for an opportunity to grow in a flexible, remote setting, we encourage you to apply!