Coordinating 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