QA CSV / MES Validation Specialist

Job Type: Contract

Location: Sanford, NC (Fully Onsite)

Duration: 1 Year

Position Summary: Seeking an experienced Quality Assurance professional with Computerized System Validation (CSV) and MES experience to provide independent Quality oversight for the implementation and validation of an Apprentice Tempo MES / Electronic Batch Record (EBR) system. The consultant will work closely with Validation, Manufacturing, IT, and project teams to ensure validation activities and documentation meet GxP, data integrity, and site Quality requirements.

Key Responsibilities: Provide QA review and approval of CSV deliverables throughout the MES/EBR implementation. Review and approve the Project Validation Plan, URS, Risk Assessments, and RTM.Review IOQ/PQ protocols, test scripts, execution evidence, and validation documentation. Review and approve validation deviations, investigations, CAPAs, and retesting. Ensure validation documentation is complete, accurate, traceable, and inspection-ready. Review and approve the Validation Summary Report (VSR) and validation conclusions. Provide Quality oversight of risk-based validation decisions and testing strategies. Support change control, system release, and go-live readiness activities. Partner with Validation, Manufacturing, IT, and technical SMEs to resolve quality and compliance issues. Ensure the final validation package meets applicable GxP and site Quality standards.

Required Qualifications: Strong QA / Quality Systems experience in a GxP pharmaceutical or biotechnology manufacturing environment. Demonstrated experience providing Quality oversight for CSV projects. Experience with MES and/or Electronic Batch Record (EBR) implementations preferred. Strong knowledge of GAMP 5 and risk-based validation. Working knowledge of 21 CFR Part 11, data integrity, electronic records/signatures, and audit trails. Experience reviewing validation lifecycle documentation including PVP, URS, Risk Assessments, IOQ/PQ, RTM, deviations, and VSRs. Strong understanding of CAPA, change control, deviation management, and Quality systems. Excellent documentation review, critical-thinking, communication, and cross-functional collaboration skills.