Process Alliance · 23 hours ago
Validation Engineer
Process Alliance is a company focused on delivering engineering solutions in a supportive and inclusive environment. They are hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment, ensuring compliance with corporate quality standards while supporting automation and system delivery.
Responsibilities
Execute new system validation and updates under change management, including reviewing validation/test plans and supporting test execution
Generate, edit, and manage CSV documentation such as requirements, traceability matrices, and test cases
Ensure all validation deliverables align with corporate quality standards, templates, and document management practices
Support change control documentation, periodic review activities, and system access/security processes
Maintain validated state of systems by tracking, reporting, and communicating document status
Collaborate with SMEs, Quality Assurance, and cross-functional teams to ensure timely and compliant execution of validation activities
Contribute to continuous improvement of CSV processes and automation delivery
Qualification
Required
BS or MS in Engineering
Kneat experience
Strong Microsoft Office skills and experience with document/change management systems
Detail-oriented with excellent communication and organizational skills
Preferred
Exposure to Control Systems, CSV, and Commissioning & Qualification