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.
