QA CSV / MES Validation Specialist

Compliance Group Inc; Sanford (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Compliance Group Inc. is seeking an experienced QA CSV / MES Validation Specialist to provide independent quality oversight for CSV and MES/EBR systems.

You will work with Validation, Manufacturing, IT, and project teams to ensure all validation activities comply with GxP, data integrity, and site requirements. The role involves reviewing validation plans, URS, IOQ/PQ, RTM, deviations, and the VSR, and ensuring inspection-ready documentation.

Qualifications

• Experience in a GxP pharmaceutical/biotech environment.
• Quality oversight for CSV projects.
• Experience with MES/EBR implementations preferred.
• Knowledge of GAMP 5 and risk-based validation.
• Working knowledge of 21 CFR Part 11, data integrity, and audit trails.
• Experience reviewing validation lifecycle docs (PVP, URS, IOQ/PQ, RTM, VSR).
• Strong CAPA, change control, deviation management background.

Responsibilities

• Provide QA review and approval of CSV deliverables during MES/EBR implementation.
• Review Project Validation Plan, URS, Risk Assessments, and RTM.
• Review IOQ/PQ protocols, test scripts, and validation documentation.
• Review and approve validation deviations, investigations, CAPAs, and retesting.
• Ensure documentation is complete, traceable, and inspection-ready.
• Approve Validation Summary Report and conclusions.
• Provide quality oversight of risk-based validation decisions and testing strategies.
• Support change control, system release, and go-live readiness.
• Collaborate with Validation, Manufacturing, IT and SMEs to resolve issues.
• Ensure final validation package meets GxP and site Quality standards.

Skills

QA / Quality Systems

Quality oversight

CSV validation

MES / EBR implementations

GAMP 5

21 CFR Part 11

Data integrity

Audit trails

CAPA

Change control

Deviations & investigations

Job description

Title : QA CSV / MES Validation Specialist

Job Type: Contract

Location : Sanford , NC (Fully Onsite)

Duration: 1 Year

Environment: GxP Pharmaceutical / Biotechnology Manufacturing

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.