Expert has a Bachelor of Science, Biomedical Engineering Degree. Managed all aspects of serialization implementation, including budget, timeline, equipment and software deployment, validation, development of new serialization processes and procedures, and customer interactions and onboarding. Provided technical support on clinical programs of all phases and commercial phase projects through validation and product launch. Directed key facility and equipment upgrades for business unit to support business growth, mitigate quality risks, and lower costs
Evaluated requests for proposal for feasibility and define processes and equipment
trains for new business opportunities
Generated protocols, reports, master batch records, validation documentation,
specifications, deviations, investigations, and CAPAs