Validation Consultant – Computer System Validation (CSV/CSA)

What You'll Do:

• Establish and maintain the firm's validation strategy and standards, ensuring all deliverables align with cGxP, GAMP 5, and data integrity principles.
• Maintain and continuously improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, and ETQ, including URS/FRS templates, risk assessments, and IQ/OQ/PQ scripts.
• Lead end-to-end client validation engagements, including validation planning, protocol authoring, execution support, evidence review, and validation summary reporting.

What They're Looking For:

• 10+ years of experience in computer system validation or computer software assurance for life science manufacturers.
• Deep working knowledge of cGxP, GAMP 5 Category 4, 21 CFR Part 11, EU Annex 11, ALCOA+, and CSA principles.
• Excellent technical and compliance writing skills, producing audit-ready validation documentation.

What They Offer:

• Remote (US) full-time position with approximately 10% travel within North America.
• Competitive benefits package including medical, dental, vision, generous PTO, and 401(k) with employer match.
• Professional development opportunities and a people-first culture backed by Pine Services Group.