Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite)

Key Responsibilities

• Lead end-to-end Computer System Validation (CSV) activities for MES and other GMP-regulated systems.
• Support validation and compliance efforts for systems and platforms including:
  • MES
  • SAP EWM (Extended Warehouse Management)
  • Tulip
  • Other GMP/GxP-regulated applications and manufacturing systems
• Prepare, review, and execute validation documentation, 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 Guidelines
  • GxP Requirements
  • Data Integrity Standards
  • IT Governance and Compliance Policies
• Execute and document validation testing activities with appropriate evidence and traceability.
• Collaborate with QA, Manufacturing, IT, Infrastructure, Automation, and third-party vendors during implementation and validation phases.
• Participate in:
  • Change Control
  • Deviation Management
  • CAPA Activities
  • Periodic Reviews
  • Audit and Inspection Readiness
• Support risk-based validation methodologies and system lifecycle management.
• Ensure systems are maintained in a validated and compliant state.

Required Skills & Experience

• 4–6 years of experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, medical device, or regulated healthcare environments.
• Strong experience validating MES and manufacturing systems.
• Solid understanding of:
  • GAMP5
  • FDA 21 CFR Part 11
  • GxP Compliance
  • Data Integrity Principles
  • SDLC and Validation Methodologies
  • IT Governance and Compliance Frameworks
• Experience authoring and executing CSV documentation and validation protocols.
• Strong knowledge of:
  • Audit Readiness
  • Change Management
  • Deviations
  • CAPA Processes
• Excellent communication, documentation, and stakeholder management skills.
• Ability to work effectively 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, digital transformation, and Industry 4.0 initiatives within life sciences.
• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.