Our client specializing in the pharmaceutical industry is looking for a Qualification Projects Engineer. Your roles and responsibilities will include:
Developing project objectives by reviewing project proposals and plans and determining project specifications by studying equipment user requirements and performance standards
Determining project responsibilities by identifying project phases and elements, preparing cost estimates, calculating time frames and preparing project schedules and timelines
Monitoring project schedules, progress, and spending
Updating qualification master plans and creating, populating and maintaining databases for tracking qualification activities, test results, and qualified systems
Prepares specific user requirement specifications (URS) for new equipment, utilities and software
Preparing, maintaining and reviewing validation or performance qualification protocols for new or modified manufacturing processes, systems, equipment, utilities and software, in accordance with internal and external quality, regulatory and safety requirements
Requirements