Coordinating Capillary Electrophoresis, iCE, CD, and MFI instrument maintenance and qualification
Serving as technical expert for both instrument hardware and software
Supporting new and existing systems through installation, configuration, validation, procedure development/review, training, troubleshooting and software/firmware management
Assist validation personnel in determining approach to validate new technologies, providing technical and/or regulatory support;
Research instrumentation with information obtained from vendors, manuals, industry resources, and other staff performing similar functions;
Work with validation group and assist in writing validation protocols, test scripts, and related documentation in accordance with established validation program; review and assess documents written by validation personnel for approach, GMP compliance, consistency, and thoroughness, consistent with internal validation procedures;
Coordinate installation and execution of validation testing, document results, assess documentation generated by vendors or other validation personnel and summarize results obtained identifying compliance with the test plan;
Perform instrument trouble-shooting and operational training when required
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