Validation Consultant – Computer System Validation, CSV/CSA

Pine Services Group

Validation Consultant serving as senior authority for computer system validation in a life science consulting firm. Establishing validation strategy and leading client engagements with ERP solutions.

Posted 7/15/2026full-timeRemote • 🇺🇸 United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA) within life sciences, ensuring compliance with cGxP, GAMP 5, and regulatory standards. Proficient in developing and maintaining validation toolkits and documentation, while effectively communicating with stakeholders across various functions.

Highest-signal resume keywords

Computer System Validation (CSV)CGxP ComplianceValidation Toolkit DevelopmentRisk-Based ValidationValidation Documentation Writing

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Validation Toolkit DesignRisk AssessmentIQ/OQ/PQ Script DevelopmentRelease Impact AnalysisValidation Summary Reporting

Soft Skills

Client Stakeholder CommunicationMentoring Junior Consultants

Tools & Technologies

QAD ERPNetSuiteQAD EQMSETQSerialization Solutions

Certifications & Qualifications

ASQ CQAASQ CQE

Industry Keywords

GAMP 5 Category 421 CFR Part 11EU Annex 11ALCOA+ PrinciplesISO 13485

Tech Stack

Tools & technologies

ERPSDLC

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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