PLM Validation Analyst

PLM Validation Analyst

Required

Education:

Bachelor's degree in Computer Science, Engineering, Business, or a related discipline.

Required Qualifications /Skills/

Experience:

3+ years of Computerized Systems Validation (CSV/CSA) experience with strong validation document authoring. Hands-on experience executing CSV/CSA in a regulated (GxP/FDA) environment. Experience authoring validation documentation, including:
User Requirements Specification (URS) Functional/Design Specifications (FS/DS) Risk Assessments Requirements Traceability Matrix (RTM) IQ/OQ/PQ Test Scripts Validation Summary Reports Experience with User Acceptance Testing (UAT), including test script development, planning, execution, defect tracking, and resolution. Experience gathering business requirements and translating them into functional/system requirements. Experience supporting Product Lifecycle Management (PLM) implementations. Experience validating workflows, system configurations, permissions, integrations, and data mapping.

Knowledge of Quality Management Systems (QMS), cGMP, GxP, and 21 CFR Part 11 compliance. Experience collaborating with cross-functional teams including IT, Business, Quality, and Validation. Strong technical documentation, analytical, organizational, and communication skills. Ability to work independently in a fast-paced implementation environment.

Preferred Qualifications /Skills/

Experience:

Experience with PLM platforms such as Agile PLM or Master Control. Experience working with software vendors during implementation projects. Experience creating process maps, work instructions, job aids, and training documentation. Experience supporting change management and user readiness activities. Knowledge of testing tools and defect management systems. Experience in cGDP-regulated environments.

PLM Validation Analyst Overview:
The PLM Validation Analyst supports the implementation, validation, and configuration of Product Lifecycle Management (PLM) systems within a regulated environment. This role partners with business, IT, quality, and validation teams to gather requirements, support system configuration, execute validation activities, develop compliance documentation, coordinate User Acceptance Testing (UAT), and ensure PLM solutions meet business, quality, and regulatory requirements.

Job Duties:

Partner with Business Analysts and stakeholders to gather and document business and system requirements. Translate business requirements into functional specifications, user stories, and system requirements. Support PLM configuration, including workflows, roles, permissions, data mapping, and supporting objects. Participate in system demonstrations, configuration reviews, and functional prototype evaluations. Develop and execute UAT test scripts and support testing activities. Track, document, and resolve testing defects through closure.

Author and maintain CSV validation documentation (URS, FS/DS, RTM, IQ/OQ/PQ, Risk Assessments, Validation Summary Reports). Ensure validation deliverables comply with QMS, GxP, cGMP, and 21 CFR Part 11 requirements. Support PLM implementation activities alongside IT, Quality, and project teams. Validate system integrations, workflows, configuration changes, and permissions. Develop process documentation, work instructions, and job aids. Support audit readiness and assist with issue resolution during validation and implementation activities.

Contribute to training materials and end-user documentation in collaboration with project stakeholders.

Only those lawfully authorized to work in the designated country associated with the position will be considered. Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.