Documentation development and execution experience (ex. - FAT, SAT, IQ, OQ, PQ, Risk Assessments, URS) in the Life Science Industry...
and execute IQ, OQ, and PQ protocols for equipment and process validation Identify, analyze, and implement process improvements...
equipment to ensure the fulfillment of all requirements including IQ/OQ/PQ validation and verification activities. Ability...
activities including IQ/OQ/PQ and MSA/GR&R to sustain validated production processes Coating Production & Supplier Support... execution) Validation methodologies (IQ/OQ/PQ), MSA/Gage R&R Quality & regulatory standards (ISO 13485, FDA, CAPA) Special...
, and manufacturing transitions Partner with Operations, Engineering, and Validation teams on IQ/OQ/PQ and revalidation efforts Monitor...
. Review and approve technical protocols, including IQ/OQ/PQ and TrackWise quality records, to ensure compliance. Conduct...
validation activities including IQ, OQ, and PQ when required. Leadership & Operator Support Train and mentor operators...
, risk assessments, control plans, and process flow documents Execute and support equipment qualifications (IQ/OQ/PQ... attention to detail Experience with IQ/OQ/PQ documentation and execution General mechanical/manufacturing engineering...
manufacturing Process Validations Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ EOL... and Executes Process Validation Strategies for EOL including Cleaning and Packaging: Creates plans, protocols (IQ, OQ, PQ...
monitoring (air, surface, personnel) Conduct utility (compressed gas) and water sampling Support PQ activities Data...