Description
Senior Process Development Engineer- develop and transfer manufacturing processes to external contract manufacturing organizations. Ensure process development and transfer activities are based on sound quality engineering principles and in compliance with applicable regulations and standards.
- Design change plans, requests, and reports
- Manufacturing process flowcharts
- Validation Master Plans, validation protocols, and validation reports
- Interface with cross-functional teams and external Contract Manufacturing Organizations to support routine product manufacturing. Ensure product manufacturing meet company quality expectations as well as applicable regulations and standards
- Interface with cross-functional teams, including Quality, Contract Manufacturing Organizations and Product Development to develop validation testing and acceptance criteria for new manufacturing equipment in accordance to pre-established timelines. Develop and write validation protocols, oversee validation execution, report on validation status, write validation deviations and reports.
- Review of GMP documents (batch records, forms, protocols, SOPs) to ensure manufacturing steps are appropriately documented, verified, and in compliance with GDP.
- Investigation / troubleshooting of equipment and process failures
- Participate in efforts related to making continuous improvements in product quality
- Implementation of process improvement efforts
- Experience with FDA (QSR), ISO 13485, MDD, and related regulations / standards
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Minimum of 5 years working experience in a process and / or quality engineering role executing equipment and process validations in the medical device industry. Experience within in-vitro diagnostics preferred.
o CAPA
o Production and Process Controls
o Risk Management
o Change control processes
o Process / Equipment Validation
To find out more about Real please visit www.realstaffing.com