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Validation Consultant – Computer System Validation (CSV/CSA)

5 hours, 23 minutes ago
United States
Full-time
Lead
Consultant
Quality Assurance and Testing
NetSuite
Apply Now
Pine Services Group

Pine Services Group

Pine Services Group supports top software partners and ISVs internationally by preserving their legacy and accelerating sustainable growth.

Internet Software & Services
View All Jobs 12

Description

  • Establish and maintain the firm's validation strategy and standards across the consulting portfolio.
  • Maintain and improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, ETQ, and related platforms.
  • Maintain standalone validation toolkits for Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.
  • Analyze software release specifications and release notes to assess validation impact, risk, and required documentation updates.
  • Build new validation toolkit frameworks for new software platforms and modules as the service portfolio expands.
  • Lead end-to-end client validation engagements, including planning, protocol authoring, execution support, evidence review, deviation handling, and validation summary reporting.
  • Provide validation guidance and execution support to client teams as embedded staff augmentation.
  • Interpret client SOPs and internal CSV/QMS requirements and tailor deliverables to client and regulatory expectations.
  • Mentor junior validation consultants and contribute to the firm's Computer Validation as a Service offering.

Requirements

  • 10+ years of experience in computer system validation (CSV) or computer software assurance (CSA) for life science manufacturers.
  • Deep working knowledge of cGxP, GAMP 5 Category 4, 21 CFR Part 11, EU Annex 11, ALCOA+, and CSA principles for risk-based validation.
  • Familiarity with 21 CFR Part 820/QMSR and ISO 13485 quality system requirements.
  • Demonstrated ability to design and maintain reusable validation toolkits, including URS/FRS templates, RTMs, IQ/OQ/PQ scripts, risk assessments, and validation summary reports.
  • Strong release impact analysis skills, with the ability to translate software release specifications into validation scope, risk, and deliverable updates.
  • Excellent technical and compliance writing skills for audit-ready validation documentation.
  • Experience executing or supporting validation protocol execution, including evidence capture, deviation documentation, and results review.
  • Proven client stakeholder communication skills across QA, IT, and business functions.
  • Experience working as staff augmentation within client teams and under client QMS and SDLC constraints.
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field; advanced degree preferred.
  • Hands-on validation experience with QAD ERP, NetSuite, QAD EQMS, or ETQ, preferred.
  • Hands-on validation experience with QAD add-ons such as Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF, preferred.
  • Experience building net-new validation toolkit frameworks for emerging software offerings, preferred.
  • Experience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers, preferred.
  • Validation-related professional certifications such as ASQ CQA and/or CQE, preferred.
  • Prior consulting experience in a continuous release validation process or managed validation services model, preferred.

Benefits

  • Remote work in the US with approximately 10% travel, primarily within North America.
  • Full-time employment.
  • Competitive benefits package including medical, dental, and vision coverage.
  • Generous PTO and company-observed holidays.
  • 401(k) with employer match.
  • Professional development opportunities.
  • People-first culture backed by Pine Services Group.

Interested in this position?

Apply directly on the company website

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