Title: Sr. Engineer Process Development (CQV)
Start Date: 8/24
Duration : 6 months +
Location: Columbus, Ohio
this is a 4-8 year candidate.
Onsite/Remote: Onsite first shift
Description: We're 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. In this role, you'll lead commissioning, qualification, and validation activities for new and existing equipment and processes, ensuring full compliance with FDA regulations and internal quality standards. You'll author and execute validation protocols (IQ/OQ/PQ), maintain master validation plans, and serve as the site's technical expert for automated systems and combination product validation.
The ideal candidate brings deep expertise in CQV within GMP-regulated environments, along with hands-on experience in automated equipment, labeling, and packaging processes. You'll collaborate closely with Engineering, Quality, and Manufacturing teams to deliver robust, validated systems that support 24/7 production operations. Flexibility to support on-site and off-shift validation activities is required
Skills: Process, CQV, Manufacturing, Packaging
Plus: Kneat Experience
Sr. Engineer – Process Development (CQV) • Columbus, OH, United States
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