Lead Validation Specialist

Senior Validation Engineer Job Description We are seeking a seasoned Validation Engineer to join our team of experts in the medical device industry. This role is responsible for creating, reviewing, executing and summarizing validation protocols. The successful candidate will provide input, critical review and approval of related validation activities associated with the production of medical devices. Process Validation Protocols: Develop, execute and summarize Process Validation Protocols (IQ, OQ, PQ, TMV) and their associated completion reports. Change Management/Change Control Assessments: Write and execute Change Management/Change Control Assessments (e.g. validation, process etc.) Engineering Changes Orders: Create and execute Engineering Changes Orders. Manufacturing Documentation: Write and approve changes related to manufacturing documentation such as Manufacturing Work Instructions, BOM, router/traveler, etc. Computer System Validation: Write and execute Computer System Validation deliverables and their associated completion reports. Troubleshooting: Troubleshoot process/equipment malfunctions. Engineering Studies: Create and execute Eng. Studies, verification runs and their associated completion reports. Requirements: Education: Engineering Bachelor's Degree. Experience: 5+ years of experience as Validation Engineer in the Medical Industry. Leadership and Communication Skills: Leadership and good communication skills. English Language Proficiency: Advanced English level.

Creado: Jue, 01 de Ene de 1970