Client is looking for a CQV Consultant to work on both new and retrofit production lines. Focus will be on single use bags, along with TFF, CIP and Chromatography Skids. Material qualification on manufacturing equipment. They are moving processes from one location to this site, along with expansions. They have some templates in place but would like this consultant to provide guidance and suggestions. Will be responsible for connecting with partners and help with packet protocols/reports, including reviewing and approving. If an issues is found, help bring to resolution. They use Veeva and will eventually be using Kneat but neither is required for the project.
Must have 5-10 years of total experience with at least 3 years of recent CQV for Pharma or Bio. Must have experience with CIP, Chromatography Skids, and TFF. Understanding of single use bags and background evaluating tubing assemblies/valves on production equipment. Experience validating assemblies on manufacturing lines. Experience reviewing documentation for equipment. Degree preferred but experience more important.
CQV, Chromatography Skids, Single Use Bags, CIP and TFF.
Hybrid in MA: CQV Consultant (232258)