Senior CSV Analyst

Definium Therapeutics

. Assist with gap assessments of existing validation packages against 21 CFR Part 11, EU GMP Annex 11 and Definium SOPs, and help plan and execute remediation .

Posted 9/24/2026full-timeRemote • United StatesSenior💰 $125,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP Computerized System Validation, including risk-based CSA approaches and compliance with 21 CFR Part 11 and EU GMP Annex 11. Proficient in technical writing and producing inspection-ready documentation while managing multiple priorities in a remote environment.

Highest-signal resume keywords

GxP Computerized System Validation21 CFR Part 11 ComplianceTechnical Writing SkillsValidation of Cloud ApplicationsExperience with Veeva Vault

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System ValidationRisk AssessmentsValidation PlansIQ/OQ/PQ ProtocolsValidation Summary ReportsData Integrity AssessmentsAudit Trail Review ProceduresValidation Impact AssessmentsValidation StrategiesChange Request Assessments

Soft Skills

Ability to Work IndependentlyTime ManagementCollaboration with Cross-Functional Teams

Tools & Technologies

Veeva VaultMedidataKneatValGenesisNetSuiteCoupa

Certifications & Qualifications

ASQ CQA

Industry Keywords

FDA-Regulated EnvironmentBiotechnologyGMPSaaS ApplicationsInspection ReadinessALCOA+ PrinciplesSOX ITGCGAMP 5ICH E6(R3)CRO Oversight

Tech Stack

Tools & technologies

CloudVault

About the role

Key responsibilities & impact

Assist with gap assessments of existing validation packages against 21 CFR Part 11, EU GMP Annex 11 and Definium SOPs, and help plan and execute remediation
Help maintain the GxP computerized system inventory, including risk classification, validation status, system ownership and supplier information
Prepare inspection-ready system summaries and storyboards
Support the inspection back room by retrieving documents, tracking and fulfilling inspector requests, and preparing system owners and SMEs to present their systems
Support responses and CAPAs arising from inspection observations and audit findings
Lead and support validation activities for new and existing GxP computerized systems using a risk-based CSA approach
Develop and review validation strategies
Author, review and execute validation deliverables, including validation plans, user and functional requirements, risk assessments, IQ/OQ/PQ protocols, traceability matrices and validation summary reports
Perform validation impact assessments for change requests, including vendor-driven SaaS releases for Veeva and Medidata
Conduct and document periodic reviews of validated systems, user access and audit trails
Document and resolve test deviations and incidents
Assist with data integrity assessments against ALCOA+ principles
Develop and perform audit trail review procedures and verify record retention and archival controls
Support decommissioning of ZenQMS following migration to Veeva Vault QMS
Support qualification and audits of GxP software suppliers and CROs, including review of vendor validation packages, SOC 2 reports and quality agreements
Help assess sponsor oversight of CRO-hosted clinical systems in line with ICH E6(R3) expectations
Coordinate with IT and Finance on SOX ITGC evidence for NetSuite and Coupa
Contribute to the evolution of the validation approach toward CSA
Contribute to updates of CSV-related SOPs, work instructions and templates

Requirements

What you’ll need

Bachelor’s degree in life science, engineering, computer science or related field, or equivalent experience
Minimum 6 years of computer system validation experience in an FDA-regulated pharmaceutical or biotechnology environment
Direct participation in at least one FDA or EMA inspection, or in a formal inspection readiness program, including back-room support
Hands-on validation of cloud or SaaS applications, including vendor-managed release cycles
Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, 312 and 314, EU GMP Annex 11, GAMP 5 and FDA data integrity guidance
Strong technical writing skills, with a record of producing clear, inspection-ready validation documentation
Ability to work independently and manage multiple priorities in a fully remote role with tight timelines
Occasional travel to headquarters, supplier or CRO sites, and to support on-site regulatory inspections
Validation experience with Veeva Vault and Medidata products preferred
Experience supporting a PAI or a company’s transition from clinical to commercial stage preferred
Practical exposure to CSA methodology preferred
Familiarity with SOX ITGC requirements at a public company preferred
Experience with electronic validation tools such as Kneat or ValGenesis preferred
Experience in small or growing companies where the validation team is lean and hands-on preferred
Professional certification such as ASQ CQA or equivalent preferred

Benefits

Comp & perks

100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
Flexible time off
Generous parental leave
Some fun fringe perks
Additional compensation, including bonus and equity may be available