Michael Dingle Email & Phone Number

Shoreview, Mn, Us

• Assist product management with global contamination control business focus on the pharmaceutical market. • Assist and support complete lifecycle management including identification, definition, implementation, and maintenance of business strategy for contamination control in the pharmaceutical and life science markets. • Collaborate with engineering, sales, service, manufacturing, and marketing to recommend future product line direction through detailed markets and financial justification.

Shoreview, Mn, Us

-Provide field support for sales staff supporting the BioTrak Real-Time Viable Particle Counter-Provide customer support in the evaluation and implementation of the BioTrak Real-Time Viable Particle Counter

Pomona, Ca, Us

QC Manager at BioTechnique:• Oversaw the startup of the Quality Control Laboratory of a contract fill/finish facility• Developed the Environmental Monitoring program• Manage a staff of 2 Chemists, 1 Microbiologist, and 6 technicians• Provide training on aseptic technique and gowning to personnel working in cleanroom• QC point of contact for clients• QC representative during auditsConsultant:Project Manager at Stratatech in Madison, Wisconsin o Lead a team of 2 environmental monitoring technicians and 2 aseptic cleanersLead Environmental Monitoring Microbiologist at Shire Pharmaceuticals in Lexington, Massachusetts. o Led a team of 3 leads and 18 technicians in support of routine environmental monitoring of cleanrooms and execution of test protocols. o Created training guides for performing environmental monitoring and water sampling. o QC Microbiology representative on numerous cleanroom studies and qualifications. o Assessed cleanroom practices and monitoring program.

Minneapolis, Mn, Us

• Served as a subject matter expert throughout Medtronic on cleanroom related issues.• Led a team from across all CVG facilities to create cleanroom and purified water policies and procedures assuring the compliance of all facilities.• Created a skill based training program for Microbiology Laboratory personnel that standardized training across CRDM global laboratories.• Working with IT staff and outside consultants, configured a Laboratory Information Management System (LabWare LIMS) for use in the Microbiology Laboratory.• Led efforts to lean out laboratory processes; this resulted in standardized laboratory workflows and improved documentations practices that greatly improved efficiency and compliance.• Represented the Microbiology Laboratory and CRDM Rice Creek cleanroom operations on multiple internal and external audits.• Performed quality system audits of laboratory suppliers.• Responsible for the successful closure of numerous CAPAs.• Developed a process for forecasting Microbiology Laboratory testing to assure testing resources would be available when needed. • Process owner of numerous cleanroom and microbiology work instructions.• Developed metrics for demonstrating the performance of the Microbiology Laboratory and Cleanroom.• Multiple time presenter at the Medtronic Packaging and Sterilization Symposium. • Member of global team for microbiology and cleanroom strategy and objective setting.• Represented the Microbiology Laboratory on the Environmental, Health and Safety Committee; conducted routine safety audits as such.• Supervised the Global Sterilization and Microbiology Laboratory. • Performed quality review of sterilization data for release of product.• Performed testing as part of the Global Sterilization and Microbiology Laboratory. The laboratory performs environmental monitoring of cleanrooms, quality control testing of products and raw materials, and testing in support of in-house ethylene oxide sterilization.

• Performed quality control testing of parenterals being manufactured for clinical trials.• Developed an environmental monitoring program for the production suites as well as the aseptic fill area.• Managed the Quality Control Laboratory. o The staff consisted of six technicians o Reviewed all test results o Scheduled testing• Represented the Quality Control Laboratory in audits.

• Supervised the production of microbiological test media made specifically to work with automated microbiology test equipment produced by the company.• Led effort to create written standard procedures for media production

Master In Engineering Management

Education record