Role & seniority: Computer System Validation (CSV) Engineer (level not specified)

Stack/tools: Kneat; Microsoft Office; document/change management systems; exposure to Control Systems, CSV, Commissioning & Qualification

Execute new system validation and updates under change management; review validation/test plans and support test execution
Generate, edit, and manage CSV documentation (requirements, traceability matrices, test cases); ensure alignment with quality standards
Maintain validated state of systems; track/report document status; collaborate with SMEs, QA, and cross-functional teams

BS or MS in Engineering preferred
Kneat experience required
Strong MS Office and document/change management skills; detail-oriented with good communication and organization

Exposure to Control Systems, CSV, and Commissioning & Qualification
Experience with continuous improvement of CSV processes and automation delivery
Location & work type: Not specified; location and work-type details not provided in the description

Full Description

We’re hiring a Computer System Validation (CSV) Engineer to support validation and lifecycle management of GxP computerized systems in a regulated pharmaceutical environment. This role focuses on ensuring compliance with corporate quality standards and applicable regulatory requirements through the development and execution of validation documentation.

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

BS or MS in Engineering preferred
Kneat experience required
Exposure to Control Systems, CSV, and Commissioning & Qualification preferred
Strong Microsoft Office skills and experience with document/change management systems
Detail-oriented with excellent communication and organizational skills

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.