Description
Validation & Engineering Group, Inc. (V&EG) is seeking a highly skilled and experienced CQV Engineer to join their team. The successful candidate will be responsible for developing, reviewing, and executing commissioning and qualification protocols for various downstream processing equipment within a GMP-regulated biotech or pharmaceutical environment. This role involves coordinating with vendors and engineering teams, performing field inspections, resolving deviations, and ensuring compliance with cGMP standards. The engineer will also author and review essential commissioning and validation documents, participate in change control evaluations, and interface with multiple departments to ensure timely project execution. The ideal candidate will have a strong understanding of downstream unit operations and associated automation, proficiency in validation protocols and electronic validation systems, and familiarity with FDA, EMA, and ICH guidelines.
