Computer Systems Validation Specialist (Part-Time)

Computer System Validation (CSV) Specialist – Consultant

Learn more about the general tasks related to this opportunity below, as well as required skills.
Location: Remote with preference for 1–2 days onsite per week in the greater Cincinnati, Ohio area.Schedule: Part-time, approximately 20 hours per weekDuration: 3 monthsStart: ASAP
Position Overview
We are seeking an experienced Computer System Validation (CSV) Specialist to support the remediation of a computer system validation program within a regulated life sciences environment.
The ideal candidate will have deep, hands-on CSV experience and be capable of independently developing complete validation lifecycle documentation, procedures, and templates from scratch. This individual should be comfortable working with minimal direction and applying a practical, risk-based approach aligned with GAMP 5 (Second Edition) and FDA Computer Software Assurance (CSA) principles.
Key ResponsibilitiesIndependently author and maintain computer system validation lifecycle documentation, including:User Requirement Specifications (URS)Functional Requirements Specifications (FRS)Risk AssessmentsValidation PlansIQ/OQ/PQ protocolsRequirements Traceability Matrices (RTM)Validation Summary Reports (VSR)Develop computer system lifecycle SOPs and standardized validation templates.Manage test deviations and incidents, including impact assessments, root cause analysis, and resolution documentation.Support change control and periodic reviews to maintain systems in a validated state.Apply GAMP 5 and CSA risk-based approaches to validation activities.Ensure compliance with requirements related to electronic records, electronic signatures, audit trails, security, and data integrity.Evaluate supplier documentation and support vendor assessments.Facilitate requirements-gathering sessions, risk assessments, and document reviews.Partner with Quality, IT, system owners, business users, and external vendors.Communicate validation risks, issues, and project status to key stakeholders.
Required QualificationsBachelor’s degree in Life Sciences, Engineering, Computer Science, Information Systems, or a related field.5+ years of hands-on CSV experience in a regulated pharmaceutical, biotechnology, medical device, or related life sciences environment.Demonstrated experience independently authoring complete validation lifecycle packages from scratch.Experience developing CSV SOPs, procedures, and document templates.
Strong working knowledge of:GAMP 5, Second EditionFDA Computer Software Assurance (CSA)21 CFR Part 11EU GMP Annex 11Data integrity / ALCOA+ principlesRisk-based validation approachesStrong technical writing and documentation skills.Ability to work independently and manage multiple priorities with minimal supervision.Strong communication and cross-functional collaboration skills.
Preferred QualificationsExperience validating systems such as manufacturing and analytical systems, eQMS, LIMS, ERP, document management, and learning management systems.Experience with cloud-hosted and SaaS platforms, including Veeva Vault.Experience with electronic validation or test management tools.Experience supporting regulatory inspections and audits.Previous consulting or multi-client experience.
Additional DetailsThis is a part-time consulting opportunity at approximately 20 hours per week. xzbcwsv Candidates who can support 1–2 days onsite per week in the greater Cincinnati, Ohio area are preferred.