Job Title: CSV & Equipment Validation Engineer

Location: North Carolina (Onsite)

Job Summary

Seeking an experienced CSV & Equipment Validation Engineer to support validation activities for computerized systems and pharmaceutical equipment, particularly within Fill/Finish operations. The role requires strong validation documentation skills, GxP compliance expertise, and hands-on experience with equipment lifecycle activities.

Required Skills & Experience

• Strong knowledge of computerized systems, equipment operations, maintenance, and decommissioning.
• SME-level experience with Fill/Finish pharmaceutical manufacturing .
• Solid understanding of GxP documentation requirements .
• Experience participating in regulatory audits and inspections .
• Proven ability to create validation protocols, test plans, and lifecycle documentation.

Responsibilities

• Plan, develop, and execute CSV and equipment validation activities.
• Create and manage validation protocols, test plans, and verification reports.
• Develop change controls, validation plans, and decommissioning documentation.
• Prepare decommissioning protocols, reports, and validation summary reports.
• Support investigations for validation deviations and corrective actions.
• Ensure compliance with GxP, internal SOPs, and applicable regulatory requirements.
• Track, review, and maintain all validation documentation.