Validation Consultant – Computer System Validation (CSV/CSA)

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 implement QAD Adaptive ERP, QAD EQMS, NetSuite, ETQ QMS, and related technologies — helping clients navigate clinical-to-commercial transitions, regulatory compliance, and operational excellence.

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
• 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

Requirements

• 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 to 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 — able to translate software release specifications into validation scope, risk, and deliverable updates
• Excellent technical and compliance writing skills, producing 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 operating as staff augmentation, integrating into client teams and working within client QMS and SDLC constraints
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field; advanced degree a plus

Qualifications

• 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
• Experience building net-new validation toolkit frameworks for emerging software offerings
• Experience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers
• Validation-related professional certifications (ASQ CQA and/or CQE)
• Prior consulting experience in a continuous release validation process or managed validation services model