CSV Validation Engineer

Katalyst-Healthcares-; Jacksonville (FL); On-site; USD 120,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced CSV Engineer to join the team in Plymouth, MN. The role focuses on developing and executing CSV strategies, creating validation documentation, and ensuring compliance with FDA, GxP, and 21 CFR Part 11 requirements.

The ideal candidate will perform risk assessments, establish traceability, and manage changes while collaborating with QA, IT, Engineering, and manufacturing teams to deliver compliant validated systems and supporting audits as

Qualifications

• 8 years of CSV validation experience in regulated environments.
• Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11.
• Excellent documentation and stakeholder management skills.

Responsibilities

• Develop and execute CSV strategies, plans, and reports.
• Create and maintain validation docs (URS, FS, DS, IQ, OQ, PQ).
• Perform risk assessments, traceability, and change control.
• Collaborate with QA, IT, Engineering, Manufacturing, stakeholders.
• Execute test scripts, deviations, investigations, and CAPA.
• Ensure compliance with FDA and data integrity requirements.
• Support system implementation, upgrades, remediation, reviews, decommissioning.
• Participate in audits and provide evidence.

Skills

CSV expertise

Regulatory knowledge

Documentation skills

Stakeholder management

Risk assessment

Audit support

Tools

Electronic documentation

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.