. Requirements: Bachelor's Degree (BSME preferred). Process Validation / IQ,OQ,PQ. Systems integration and Manufacturing process...
with lab equipment lifecycle activities, including setup, qualification (IQ/OQ/PQ), calibration/verification, maintenance...
validations, OQ/PQ studies, design of experiments, transit testing, aging studies, sterilization validations, and ongoing process...
of process and equipment validation / qualifications (IQ, OQ, PQ). Assist in QA review and approval of software user acceptance...
handling, and integration monitoring in GMP environments. GxP/CSV: GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, IQ/OQ/PQ...
's/documents, etc) Write & Execute PQ's;Lead/Own CAPA's;Support HRA's/HHE's Model all quality values and coaches others on BSH...
travel to CP and PQ as required, notionally alternating weeks of 1-3 days duration. Position reports to VP Ops Excellence...
. Technical ability to complete qualification (IQ/OQ/PQ) requirements, read and interpret hydraulic prints and electrical...
. Technical ability to complete qualification (IQ/OQ/PQ) requirements, read and interpret hydraulic prints and electrical...
as needed Support integration of new equipment into validated manufacturing environments (IQ/OQ/PQ support) Collaborate with cross...