Validation Consultant

7 days ago


Wilmington, United States Intellectt Inc Full time

Position: Computer System Validation Engineer (CSV Engineer) – Mid Level

Location: Wilmington, NC


Job Overview:

This mid-level CSV Engineer role requires experience in validating non-product software within the healthcare sector, ensuring adherence to FDA regulations. The role is crucial for validating computer systems used across development, manufacturing, and quality assurance.


Key Responsibilities:

  • Validation of Non-Product Software: Validate software tools like MasterControl, Veeva Vault, TrackWise, SAP, and Oracle to comply with FDA standards.
  • Risk Assessment: Conduct risk assessments to prioritize validation tasks.
  • Documentation: Create and maintain key documents, such as User Requirements Specifications (URS), Validation Plans, Test Protocols (IQ, OQ, PQ), and Final Validation Reports.
  • Validation Execution: Conduct IQ, OQ, and PQ tests to ensure the software functions correctly in operational settings.
  • Collaboration: Work closely with IT, Quality Assurance, and Regulatory Affairs to align validation strategies.
  • Compliance and Standards: Apply FDA guidelines (21 CFR Part 820), GAMP 5, and risk management practices to validation activities.


Qualifications:

  • Education: Bachelor’s/Master’s degree in Computer Science or related field.
  • Experience: Proven experience in software validation within regulated environments and semiconductor manufacturing is a plus.
  • Skills: Strong analytical, communication, and documentation skills; familiarity with software testing methodologies.
  • Tools and Knowledge: Proficient in various validation tools, able to work both independently and within global cross-functional teams.


====================================


Position: CQV

Location: Vernon Hills, IL

Duration: 6+ months


Key Responsibilities:

  • Equipment Support: Oversee equipment delivery, installation, and compliance with HSE policies.
  • Project Management: Manage schedules, deliverables (HSE plan, RACI, risk analysis), progress tracking, and communications.
  • Risk & Resource Management: Identify/assess risks, prioritize tasks, manage resources, and support CQV deliverables (Requirements, Protocols, Reports).
  • Testing & Documentation: Assist with Pre-SAT, SAT, PQ execution and documentation, and prepare training materials.


Required Skills:

  • 5+ years in equipment installation and CQV.
  • Knowledge in automation, engineering disciplines, safety, and scheduling.
  • Strong judgment, independent decision-making, and proactive issue resolution.
  • Effective verbal and written communication.


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