Mitchell Winters Email & Phone Number

Tampa, Florida, United States

- Support and lead capital project execution by performing activities related to equipment life cycle including but not limited to change management packages, operation manual creation, standard operating procedures, FAT, commissioning, and qualification.- Participate and lead process validation activities including protocol development, commissioning, qualification, and report writing.- Perform process development and technology transfer for new products into the manufacturing facility through design and execution of experimental and validation protocols. - Support and lead manufacturing continuous improvement projects including safety and compliance. - Provide technical support for aseptic filling/compounding operations including process troubleshooting, optimization, and improvement initiatives. - Conduct process investigations and root cause analyses to identify and address deviations, non-conformances, and other process related issues, implementing corrective and preventive actions as necessary.- Perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.

Minneapolis, Minnesota, United States

- Manage large engineering capital projects including all aspects of procurement, installation, testing, and qualification. - Organize, design, and generate all relevant data to prepare project scopes, cost estimates, economic justification, and capital appropriation requests.- Create and update GMP documentation as needed by the designated project including but not limited to URS documentation, equipment qualifications, change controls, SOPs, and equipment operation manuals.- Participate in site audits by health authorities or other regulatory agencies (e.g. FDA/OSHA).- Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent recurrence. - Troubleshoot complex equipment related issues and develop sound engineering solutions to address identified problems for assigned systems. - Support site reliability efforts by monitoring key equipment performance variables and proactively identify and address issues before they cause unplanned equipment downtime. - Equipment and system design of transferrable liquid product throughout the facility.

Minneapolis, Minnesota, United States

Ames, Iowa, United States

Project team lead for nanoparticle loaded foam project:- Developed a hybrid nanoparticle foam drug delivery system to target conditions affecting the lower gastrointestinal tract.Project team lead for stem cell deposition using computational methods:- Developed a program software to predict the optimization of stem cell deposition.

Plymouth, Minnesota, United States

- Provided engineering support for designing and developing medical devices.- Compounded various drugs with thermoplastic polyurethanes to test the elution and release rate of diverse polymers. - Fabricated conductive silicones and measured the resistivity of those silicones.