Validation Consultant - Computer System Validation CSV/CSA - Pine Services

One of Pine's portfolio companies is a leading consulting firm specializing in ERP, quality management, and manufacturing solutions for life science manufacturers. They implement QAD Adaptive ERP, QAD EQMS, NetSuite, ETQ QMS, and related technologies — helping clients navigate clinical-to-commercial transitions, regulatory compliance, and operational excellence. 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.

The successful candidate will establish and maintain the firm's validation strategy, extend its validation toolkits across QAD, NetSuite, QAD EQMS, ETQ, and supporting add-on platforms, and lead end-to-end validation delivery on client engagements. This role works alongside the current Validation Practice Lead and is accountable for ensuring every validation package produced is inspection-ready and aligned with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and data integrity expectations.

This is a full-time primarily role with approximately 10% travel to client sites, primarily within North America.

What You'll Do

• 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.
• Analyze software release specifications and release notes to determine validation impact, risk, and required deliverable 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 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.
• Interpret client SOPs and internal CSV/QMS requirements, tailoring deliverables to meet both client-internal and regulatory expectations.
• Mentor junior validation consultants and contribute to the firm's Computer Validation as a Service (CVaaS) offering.

What They're Looking For

Required

• 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 applied