Senior CSV Validation Engineer – GxP & FDA Regulated

Creative Solutions Services, LLC; 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

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