Our client recently completed a Gap assessment, and the procedures are fully written. They need a Senior Level Process engineer (10+ years of Experience) with a strong Pharma background onsite to help implementing DQP (development quality practices)/GMP principals. This person will be working with the labs individually.
This project will require authoring instrument procedures, creating equipment binders, working with third party vendors and IT, implement user access controls and audit trail, where applicable, etc. These resources will be required to work independently with little to no oversite. The engineer must have experience as a system owner for analytical equipment. This includes calibration, qualification, and maintenance of analytical systems and equipment
Sr. Process Engineering in a Pharma environment in the developmental space. There is no QA oversite for this project.
Familiarity with Equipment, software, pharma lab (analytical equipment, bioreactors, etc) – Writing instrument procedures, back up schedules, etc.
Familiarity with Equipment lifecycle.
Familiarity with Validation, GMP settings, FMEA / Risk, understanding the rational.
Communication with the Laboratories – will need to have the ability to speak to Lab people coming from an acedemia / scientist background.
Plus’s: Cell / Gene therapy / DNA, Project Management
San Diego CA: Process for GMP (232581)