Validation Consultant – Computer System Validation, CSV/CSA

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Pine Services Group

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2021

💼 Conseil

📦 Logistique

📣 Marketing

Consulting • Logistics • Marketing

Pine Services Group est une société mondiale de portefeuille à long terme au sein d'Evergreen Services Group, qui s'associe à des entreprises de services ERP et de technologie, les acquiert et les soutient. Elle préserve l'identité et l'indépendance des entreprises de son portefeuille tout en offrant une clarté financière, un soutien stratégique et opérationnel (recrutement, ventes/marketing, infrastructure), et une communauté de pairs pour favoriser une croissance durable et à long terme pour les entreprises axées sur les systèmes ERP, les applications métier et les services informatiques gérés.

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.

🎯 Exigences

• 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.

🏖️ Avantages

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