CSV Validation Engineer

JobDiva, Inc.; Plymouth (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced CSV Engineer to join our team in Plymouth, MN. You will lead validation efforts for computer systems in regulated environments, ensuring compliance with GxP, GMP and FDA regulations.

Responsibilities include developing CSV strategies, creating validation documents, performing risk assessments, and supporting audits. Strong documentation and stakeholder management skills are essential.

Qualifications

• 8+ years of experience in Computer System Validation (CSV) in regulated environments.
• Strong knowledge of GxP, GMP, FDA regulations and 21 CFR Part 11.
• Experience with validation methodologies and risk-based validation.
• Excellent documentation, communication and stakeholder-management skills.

Responsibilities

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

Skills

GxP compliance

Data integrity

Documentation

Stakeholder management

Communication

Job 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.