Validation Consultant – Computer System Validation, CSV/CSA

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Pine Services Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2021

🤝 B2B

🏢 Enterprise

☁️ SaaS

B2B • Enterprise • SaaS

Pine Services Group is a long-term global holding company within Evergreen Services Group that partners with, acquires, and supports ERP and technology-enabled services businesses. It preserves the identity and independence of portfolio companies while providing financial clarity, strategic and operational support (recruiting, sales/marketing, infrastructure), and a peer community to drive sustainable, long-term growth for firms focused on ERP systems, business applications, and managed IT services.

📋 Description

• 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

• 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. • 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.

🏖️ Benefits

• Competitive benefits package (medical, dental, vision) • Generous PTO and company-observed holidays • 401(k) with employer match • Professional development opportunities • People-first culture