/OQ/PQ) Experience with aseptic processing, HVAC systems, or utilities Familiarity with ISO standards and FDA audits...
process validation planning and execution. Assume full ownership of PQ process validation planning, execution, and reporting...
. Experience leading CAPA and process validation (IQ/OQ/PQ) projects Experience in owning the introduction of new products...
, fixtures and tools. Perform IQ/OQ/PQ validation activities Participate in the introduction of new products into manufacturing...
from initiation through IQ/OQ/PQ, aligning stakeholders and timelines to deliver right-first-time qualifications. Technology... in analytical equipment qualification and lifecycle (IQ/OQ/PQ/periodic review). Expertise with asset management/CMMS software...
validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does not discriminate on the basis of race...
& Qualification Support Partner with Quality and Validation teams to support IQ/OQ/PQ for solid dose equipment and supporting... regulatory standards. Experience supporting process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ...
Qualifications (EM PQ) and overseeing the execution. (EM) Evaluating EM data and authoring EM Trend Reports. (EM) Assist...
, mechanical systems, controls, and integration. Experience with FAT/SAT, commissioning, and qualification (IQ/OQ/PQ... activities (IQ/OQ/PQ). Coordinate with vendors, system integrators, and internal maintenance teams to ensure equipment...
. Understanding of Test Method Validation, IQ, OQ, PQ approach as defined by AtriCure Quality System. Manufacturing Logistics...