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Validation Consultant – Computer System Validation, CSV/CSA
Location
United States
Posted
3 days ago
Salary
0
Seniority
Lead
Job Description
Validation Consultant – Computer System Validation, CSV/CSA
Pine Services Group
• 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.
Job 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
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