Education & Experience: 8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments. Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.
Numbers & Facts
Location
Plymouth, MN
Description
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.