Quality Assurance Engineer

IntePros is seeking a Quality Assurance Engineer to support the implementation and validation of a new Product Lifecycle Management (PLM) system. This project-focused role will ensure a successful, compliant system deployment through Computer System Validation (CSV), User Acceptance Testing (UAT), and collaboration with Quality, IT, and business teams.

Responsibilities:

• Support PLM implementation, validation, and legacy data migration
• Gather and document business and system requirements (URS, FS/DS, RTM)
• Develop and execute CSV/CSA deliverables, including IQ/OQ/PQ protocols and validation reports
• Create and execute UAT test scripts, track defects, and support issue resolution
• Partner with Quality, IT, and cross-functional teams to ensure GxP compliance and a successful system go-live
• Develop system documentation, process maps, work instructions, and training support materials

Requirements:

• Bachelor's degree in Engineering, Computer Science, Business, or a related field
• 3+ years of Computer System Validation (CSV/CSA) experience in a regulated environment
• Experience authoring validation documentation, test protocols, and traceability matrices
• Knowledge of GxP, FDA, cGMP, and 21 CFR Part 11 requirements
• Experience with PLM systems (Agile, MasterControl, or similar) and software implementation projects
• Strong analytical, technical writing, and cross-functional communication skills
• PLM Implementation
• CSV/CSA
• UAT
• GxP
• 21 CFR Part 11
• Requirements Gathering
• Validation Documentation
• Quality Systems