Qualification Projects Engineer

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

• Project management experience in a manufacturing environment
• Experience in multiple GMP qualification disciplines
• Good command of design and visualisation software such as AutoCAD and Inventor
• Advanced Microsoft Office skills

• Degree in Engineering or equivalent qualification