Validation Engineer III

About the role

The Validation Engineer III plays a crucial role in ensuring that all validation activities are conducted in compliance with FDA regulations and company standards. This position requires strong technical skills and the ability to collaborate effectively with various departments.

Responsibilities

• Lead interactions and collaborations with cross-functional departments to meet company expectations
• Oversee and review validation area processes and procedures
• Prepare and execute validation protocols for equipment, utility systems, facilities, processes, and automation systems
• Generate and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems
• Generate and maintain inventory of GMP systems and requalification/revalidation schedules
• Conduct risk assessments for GMP systems as required
• Plan validation efforts according to risk
• Collaborate with clients, CMO's, and vendors to meet project and company objectives
• Troubleshoot and resolve discrepancies reported during validation/qualification
• Troubleshoot, coordinate, and resolve failure investigations for manufacturing and laboratory equipment
• Provide technical input to assist in development of project planning
• Provide technical project management deliverables for certain phases of a project including but not limited to scheduling, design, estimates, engineering specifications, drawings, materials procurement, construction contracts, cost tracking and project cost projections
• Partner with engineering studies and investigation studies as applicable
• Lead audits and regulatory agency inspections for Validation
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process with vendors
• Own the communications process