Engineer, Quality Assurance

Wilson•Cary, IL

1d•Hybrid

About The Position

We are seeking an Engineer, Quality Assurance to support the implementation and validation of a replacement Product Lifecycle Management system. This project will include data and records migration from a legacy PLM platform, along with integration between the new PLM system and the Manufacturing Execution System. This is a project-based role focused on Computer System Validation, also known as CSV, and Computer Software Assurance, also known as CSA. The contractor will support requirements documentation, PLM configuration activities, User Acceptance Testing, GxP validation deliverables, and compliant system adoption through go-live. The ideal candidate will have hands-on experience in CSV/CSA within a regulated environment, strong validation documentation skills, experience translating requirements into testable deliverables, and exposure to PLM, QMS, document management, or similar regulated systems.

Requirements

Bachelor’s degree in Computer Science, Engineering, Business, or a related discipline.
3+ years of experience in Computerized System Validation and/or Computer Software Assurance.
Strong experience authoring validation documentation in a regulated environment.
Hands-on CSV/CSA execution experience.
Experience authoring test scripts, protocols, traceability documentation, and validation summary documentation.
Experience translating business and system requirements into testable validation deliverables.
Experience with GxP, FDA-regulated systems, and regulated system implementation projects.
Experience working in cGMP, cGDP, or 21 CFR Part 11 regulated environments preferred.

Nice To Haves

Experience supporting QMS, PLM, document management, MES, or other regulated enterprise systems.
Prior experience supporting PLM software implementation and validation.
Knowledge of PLM systems such as Agile, MasterControl, or similar platforms.
Experience supporting data migration, records migration, or system integration validation.
Experience working with vendors during software implementation projects.
Experience with UAT planning, testing tools, defect management, and evidence collection.
Experience supporting system configuration reviews, workflow validation, permissions testing, or integration testing.
Experience developing process maps, work instructions, job aids, or training support materials.
Familiarity with CSV, CSA, GAMP, risk-based validation, and requirements traceability.

Responsibilities

Partner 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 business requirements, system specifications, and PLM configuration.
Support user readiness and change activities by identifying differences between current-state and future-state processes.
Assist in documenting process changes, system impacts, and user requirements related to the PLM implementation.
Collaborate with System Administrators to support PLM workflow configuration, data mapping, roles, permissions, and supporting system objects.
Work under the guidance of system architects to ensure configuration activities align with the overall solution design.
Support functional prototypes, system demonstrations, and iterative configuration reviews.
Participate in configuration review sessions to identify validation impacts and testing readiness needs.
Partner with technical and integration teams to ensure PLM configuration aligns with system architecture, data models, and integration requirements.
Develop functional test scripts to support User Acceptance Testing and system validation cycles.
Support UAT planning, readiness activities, execution, and evidence collection.
Assist business testers with test execution, issue resolution, defect logging, and documentation.
Track defects, retesting, and resolution activities through closure.
Validate that system functionality meets defined requirements and supports intended use.
Ensure test documentation is complete, accurate, and aligned with validation and quality expectations.
Author and maintain validation documentation in support of PLM implementation and system validation.
Create and support validation deliverables, including: User Requirements Specification, Functional Specifications and/or Design Specifications, Risk assessments aligned with CSV and CSA principles, Requirements Traceability Matrix, IQ, OQ, and PQ test scripts, Test Summary Reports and/or Validation Summary Reports.
Ensure validation deliverables comply with internal Quality Management System requirements, GxP expectations, and applicable regulatory requirements.
Support validation strategy, testing execution, documentation review, and audit readiness activities.
Work closely with IT, Quality, Validation, and project teams to support a smooth and compliant PLM implementation.
Support validation of PLM integrations, workflows, permissions, configuration changes, and data migration activities.
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, job aids, and supporting user documentation.
Provide functional input to support training materials and user guides in partnership with the Training Lead.
Support go-live readiness by ensuring requirements, testing, validation, documentation, and user readiness activities are completed within project timelines.