CSV Validation Engineer

Summary:

We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN.

Roles & Responsibilities:

• Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports.
• Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports.
• Perform risk assessments, impact assessments, traceability, and change control activities.
• Support validation of GxP-regulated computerized systems in accordance with applicable regulations and company procedures.
• Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.
• Execute and document test scripts, deviations, investigations, and CAPA activities.
• Ensure compliance with FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
• Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
• Participate in audits and provide validation documentation and evidence as required.

Education & Experience:

• 8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments.
• Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and data integrity.
• Experience with validation methodologies, risk-based validation, and electronic documentation.
• Excellent documentation, communication, and stakeholder-management skills.