Computer Systems Validation (CSV) Analyst – PLM Implementation - REMOTE

We are hiring Computer Systems Validation (CSV) Analyst – PLM Implementation - REMOTE.Please let me know if you are interested or anyone who might be interested.Client: Major Medical Device ClientPosition: Computer Systems Validation (CSV) Analyst – PLM Implementation - REMOTEDuration: 9+ months on W2Location: REMOTE or Onsite in Cary, IL 60013Pay Rate: $45.00-$50.00/ Hr on W2___________________________________________________________________________________________Job DescriptionSummaryThe contractor in this role will support the implementation and validation of a replacement Product Lifecycle Management (PLM) system, including data and records migration from the legacy PLM platform and seamless integration with the Manufacturing Execution System (MES).This is a project-based role focused on Computer System Validation (CSV), including documenting user requirements, supporting PLM configuration, and developing User Acceptance Testing (UAT) and GxP system validation deliverables. The role plays a critical part in ensuring compliant, high-quality system adoption and a successful go-live.Essential Duties & ResponsibilitiesUser Requirements and System AnalysisPartner with Business Analysts to conduct requirements elicitation sessions with business stakeholders.Translate business needs into clear, testable functional requirements, user stories, and system requirements.Ensure alignment between requirements, system specifications, and PLM configuration.Support user readiness and change management activities by identifying gaps between current and future-state processes.PLM Configuration SupportCollaborate with System Administrators to support configuration of PLM workflows, data mapping, roles, permissions, and supporting objects under the guidance of system architects.Support functional prototypes, system demonstrations, and iterative configuration reviews.Participate in configuration review sessions to identify validation impacts and support testing readiness.Work closely with technical and integration teams to ensure PLM configuration aligns with overall system architecture and data models.User Acceptance Testing (UAT)Develop functional test scripts to support UAT and system validation cycles.Support UAT planning, readiness activities, and execution.Assist business testers with issue resolution, defect logging, and evidence collection.Track defects, retesting, and resolution through closure.Validate that system functionality meets defined requirements and intended use.Computer System Validation (CSV)Author and maintain validation documentation, including:User Requirements Specification (URS)Functional and/or Design Specifications (FS/DS)Risk Assessments aligned with CSV and CSA principlesRequirements Traceability Matrix (RTM)Test Scripts (IQ/OQ/PQ)Test Summary Report / Validation Summary ReportEnsure validation deliverables comply with Quality Management System (QMS) requirements, GxP expectations, and applicable regulatory requirements.PLM Implementation SupportWork closely with IT, Quality, and project teams to support a smooth and compliant PLM implementation.Partner with Quality and Validation teams to address findings, resolve gaps, and support audit readiness.Develop and maintain system documentation, including process maps, work instructions, and job aids.Support validation of system integrations, workflows, permissions, and configuration changes.Provide functional input to support development of training materials and user guides in collaboration with the Training Lead.EducationBachelor's degree in Computer Science, Engineering, Business, or a related field.3+ years of experience in Computer System Validation (CSV/CSA), with strong document authoring experience.Experience working in a regulated environment (cGMP, cGDP, and 21 CFR Part 11) preferred.Qualifications & ExperienceHands-on CSV/CSA execution experience in a regulated environment.Experience authoring validation documentation, including test scripts, protocols, and traceability matrices.Experience with GxP/FDA-regulated systems.Ability to translate business requirements into validation and testing activities.Experience with requirements gathering, functional analysis, and system configuration.Experience supporting QMS, PLM, or document management systems.Prior experience with PLM software implementation and validation.Working knowledge of PLM platforms such as Agile PLM, MasterControl, or similar systems.Experience collaborating with software vendors during implementation projects.Knowledge of UAT planning, testing methodologies, and defect management tools.Ability to work independently and meet project deadlines in a fast-paced environment.Preferred SkillsExperience with PLM-to-MES integrations.Familiarity with Computer Software Assurance (CSA) principles.Strong understanding of risk-based validation methodologies.Experience supporting pharmaceutical, biotechnology, or medical device environments.RegardsVishnu Das Natesandvishnu@radiants.com