Pine Services Group

Pine Services Group

Validation Consultant – Computer System Validation (CSV/CSA)

United States · Full-time

Sponsorship not specifiedDetected 6 days ago
ComplianceStakeholder ManagementERPMedical DevicesCommunicationWritingNetSuite

About the role

  • One of Pine's portfolio companies is a leading consulting firm specializing in ERP, quality management, and manufacturing solutions for life science manufacturers.
  • They're looking for a Validation Consultant to serve as a senior technical authority for computer system validation (CSV) and computer software assurance (CSA) across their life science consulting portfolio.
  • This is a full-time primarily role with approximately 10% travel to client sites, primarily within North America.

Responsibilities

  • Establish and maintain the firm's validation strategy and standards, ensuring all deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles.
  • Maintain and continuously improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, and ETQ - including URS/FRS templates, risk assessments, requirements traceability matrices (RTMs), IQ/OQ/PQ scripts, and script libraries.
  • Maintain standalone validation toolkits for Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.
  • Build new validation toolkit frameworks for new software platforms and modules as the service portfolio expands.
  • Lead end-to-end client validation engagements, including validation planning, protocol authoring, execution support, evidence review, deviation handling, and validation summary reporting (VSR).
  • Provide validation guidance and execution support to client teams as embedded staff augmentation.
  • Demonstrated ability to design and maintain reusable validation toolkits, including URS/FRS templates, RTMs, IQ/OQ/PQ scripts, risk assessments, and validation summary reports.

Requirements

  • Analyze software release specifications and release notes to determine validation impact, risk, and required deliverable updates.
  • 10+ years of experience in computer system validation (CSV) or computer software assurance (CSA) for life science manufacturers.

Nice to have

  • Hands-on validation experience with QAD ERP, NetSuite, QAD EQMS, or ETQ.
  • Hands-on validation experience with QAD add-ons including Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.
  • Validation-related professional certifications (ASQ CQA and/or CQE).
  • Prior consulting experience in a continuous release validation process or managed validation services model.
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field
  • advanced degree a plus.
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This listing is sourced directly from Pine Services Group's careers page and normalized into a canonical job model.