Senior CSV Engineer - Kneat Implementation

Key Responsibilities

• Develop UAT scenarios, test scripts, and supporting test documentation.
• Capture, analyze, and report defects during UAT execution.
• Coordinate UAT execution, evidence collection, retesting, and traceability.
• Create and update Standard Operating Procedures (SOPs), work instructions, job aids, templates, and validation documents.
• Manage controlled documents through electronic document management workflows.
• Support requirements traceability, document tracking, and deployment readiness.
• Develop training materials and user communications.
• Support change control, go-live, and hypercare activities.
• Track user access, training completion, open actions, and implementation readiness.
• Cross-functional coordination with Quality, IT, Engineering, C&Q, site teams, SMEs, and vendors.
• Support multilingual document and translation activities as needed.

Required Qualifications

• 5+ years of experience in CSV, validation, quality, engineering, or regulated life sciences environments.
• Hands-on experience with UAT, test scripts, validation documentation, or system implementation.
• Knowledge of GxP, CSV, CSA, or regulated computerized systems.
• Experience with SOPs, work instructions, test documentation, or controlled documents.
• Strong organizational, writing, communication, and stakeholder-management skills.

Preferred Skills

• Kneat or similar digital validation platforms.
• HP ALM/Quality Center, Jira, or similar test-management tools.
• Veeva Vault, Documentum, BMSDocs, or similar document-management systems.
• Experience with enterprise or multi-site implementations.
• Experience with change control, training readiness, go-live, and hypercare.
• Experience supporting multilingual documentation.