Job Description

Position Title: Senior Computer System Validation (CSV) Lead Consultant
Location: Concord, NC (Onsite)

Duration: 12 Months

Job Summary

Experienced Senior Computer System Validation (CSV) Consultant to support validation and compliance activities for MES and other GMP-regulated systems within the pharmaceutical/life sciences environment. The ideal candidate should possess strong expertise in Computer System Validation (CSV), IT Governance, and Compliance, with hands-on experience validating manufacturing and enterprise systems in regulated environments.

The consultant will work closely with Quality, Manufacturing, IT, Compliance, and Business teams to ensure systems remain compliant with FDA regulations, GAMP5 guidelines, 21 CFR Part 11, and internal quality standards throughout the system lifecycle.

Key Responsibilities

• Lead end-to-end Computer System Validation (CSV) activities for MES and GMP-regulated systems.
• Support validation and compliance activities for systems/tools including:
  • MES platforms
  • EWM
  • Tulip
  • Other GMP/GxP-regulated applications and manufacturing systems
• Prepare, review, and execute validation deliverables including:
  • Validation Plans (VP)
  • User Requirement Specifications (URS)
  • Functional/Design Specifications (FS/DS)
  • Risk Assessments
  • IQ/OQ/PQ Protocols
  • Traceability Matrix
  • Validation Summary Reports (VSR)
  • SOPs and Work Instructions
• Ensure compliance with:
  • FDA 21 CFR Part 11
  • GAMP5
  • GxP requirements
  • Data Integrity standards
  • IT Governance and Compliance policies
• Execute and document validation testing activities with proper evidence and traceability.
• Collaborate with QA, Manufacturing, IT, Infrastructure, Automation, and external vendors during implementation and validation activities.
• Participate in change control, deviation management, CAPA, periodic reviews, and audit/inspection readiness activities.
• Support risk-based validation approaches and system lifecycle management.
• Ensure systems are maintained in a validated and compliant state.

Required Skills & Experience

• 8+ years of experience in Computer System Validation (CSV) within pharmaceutical, biotech, medical device, or regulated healthcare environments.
• Strong experience in MES validation and manufacturing systems compliance.
• Strong understanding of:
  • GAMP5
  • FDA 21 CFR Part 11
  • GxP compliance
  • Data Integrity principles
  • SDLC and validation methodologies
  • IT Governance and Compliance frameworks
• Experience in authoring and executing CSV documentation and protocols.
• Strong knowledge of audit readiness, deviations, CAPA, and change management processes.
• Ability to work with cross-functional and global teams.

Preferred Qualifications

• Experience with cloud/SaaS validation in regulated environments.
• Familiarity with Agile and risk-based validation methodologies.
• Exposure to manufacturing, automation, and digital transformation initiatives in life sciences.
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.

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