What You'll Do
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.
What They're Looking For
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.
Nice to Have
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.