Senior Computer System Validation Specialist

ACM Global Laboratories

. Lead risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle .

Posted 10/5/2026full-timeRemote • New York • United StatesSenior💰 $105,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computerized System Validation (CSV), Change Control, and Software Development Life Cycle (SDLC) within GxP-regulated environments, ensuring compliance with regulatory standards and effective risk management. Proven ability to lead validation activities, mentor teams, and maintain documentation integrity throughout system lifecycles.

Highest-signal resume keywords

Computerized System Validation (CSV)Change ControlSoftware Development Life Cycle (SDLC)Regulatory Compliance (GxP, 21 CFR Part 11, EU Annex 11)Technical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk-Based ValidationValidation Lifecycle DeliverablesData IntegrityElectronic Records/SignaturesValidation Strategy ExecutionAudit ReadinessTesting ProtocolsChange Impact AssessmentsUAT EvidencePeriodic Reviews

Soft Skills

Analytical SkillsCommunication SkillsFacilitation SkillsPrioritizationMentoring

Industry Keywords

GxPCSV/CSAGAMP 5Regulatory RequirementsCAPAsDeviationsRemediation PlansInspection ReadinessLifecycle ProcessesDocumentation Maintenance

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Lead risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle
Provide technical leadership in validation strategy, execution, quality review, audit and inspection readiness
Serve as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements
Author, review, or approve validation lifecycle deliverables, including risk assessments, validation or assurance plans, specifications, testing protocols, UAT evidence, traceability matrices, summary reports, periodic reviews, change impact assessments, migration, archival, decommissioning, and retirement documentation
Provide IT Quality and Compliance oversight for computerized systems, SDLC activities, validation deliverables, change controls, and lifecycle processes
Support audits, inspections, audit responses, CAPAs, deviations, remediation plans, and validation-related observations
Support procurement, implementation, configuration, validation, operational use, change control, periodic review, incident/deviation support, migration, archival, and retirement
Ensure validated systems remain in a state of control through change assessment, regression testing, periodic review, access/security review, backup/restore review, data integrity review, and documentation maintenance
Provide senior-level review and guidance for change controls, impact assessments, validation strategy decisions, test planning, evidence review, and release readiness
Provide technical leadership, coaching, and mentoring to CSV/CSA Specialists and cross-functional project teams
Support development and improvement of validation procedures, templates, guidance documents, training materials, metrics, and operating rhythms
Facilitate cross-functional meetings and communications related to validation strategy, compliance expectations, audit readiness, and lifecycle deliverables
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field OR equivalent combination of education and relevant experience
5+ years of CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems experience
Strong knowledge of computerized system validation, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, and e-record/e-signature expectations
Strong working knowledge of validation lifecycle deliverables and risk-based validation practices
Ability to interpret regulatory expectations and apply them pragmatically to system risk, intended use, and business impact
Strong technical writing, documentation review, inspection-readiness, analytical, prioritization, facilitation, and communication skills
Experience leading validation strategy and deliverable execution for laboratory, quality, clinical, enterprise, infrastructure, data, or integration systems
Experience supporting audits, inspections, CAPAs, deviations, remediation activities, SDLC reviews, change controls, testing evidence, data integrity controls, and lifecycle records
Experience mentoring or providing technical guidance to less senior validation or quality resources
Ability to lead complex validation activities across multiple systems, projects, stakeholders, and priorities
Ability to work remotely; East Coast preferred