Job Description:

We are seeking a highly skilled Sr. Engineer Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.
Roles & Responsibilities:

• Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.


• Author, review, and execute valid...