John Molewyk Email & Phone Number

Raleigh, NC, US

Greater Grand Rapids, Michigan Area

• MOLEWYK, LLC, Grand Rapids, Michigan (2009-present)Molewyk, LLC is my independent consulting firm that specializes in applying Quality improvements through Lean/Six Sigma, Project Management and Concurrent Engineering.
• Performed corporate quality system assessments, led remediation of Investigation/CAPA system, and led team that created policy documents, high level SOPs, and User Requirement Specifications for electronic Quality.
• Executed consent decree baseline audits at facility that produces aseptically filled and lyophilized SVPs, as an independent consultant for Compliance Partners/PAREXEL International.
• Conducted investigations, root cause analysis, and CAPA development/implementation for pharmaceutical site under consent decree that manufactures aseptically filled and lyophilized SVPs.
• Benchmarked and performed gap analysis for Hollister International’s Design for Manufacturability and Assembly (DFMA) training program.

Grand Rapids Micigan

Towel Tracker, LLC is a second stage high tech company that was founded in 2009 and was named one of Michigan’s “50 Companies to Watch” in 2017. It manufactures the patented RFID-based Towel Tracker, which eliminates towel theft at hotels, resorts, and fitness clubs in 20 states plus Puerto Rico. Towel Trackers dispense pool towels embedded with washable.

Supervised maintenance department (28 mechanics, 2 engineering technicians, and 2 exempt supervisors) responsible for servicing all production equipment used to manufacture and package injectable vials and ampules, 200 mL-500mL glass bottles, and 50-2000 mL filled IV bags. Areas serviced also included aseptic filling and lyophilization, as well as terminal.

North Chicago, Illinios

Managed the Maintenance department (32 employees on three shifts) that serviced all production equipment used to manufacture and package 50 mL-2000mL filled IV bags

Production Supervisor (Abbott Laboratories;1999-2001)Supervised a two-shift operation of 37 total employees on four production lines, producing terminally sterilized emulsions in 5-500 mL glass containers, with an emphasis on productivity and quality improvement using Lean Six Sigma methodologies.

Abbott Park, Illinios

Member of the Hospital Products Division Technical Services Group, which helped internal clients identify and implement solutions to processes and packaging components used in manufacturing sterile pharmaceuticals and devices. Designed and assessed new or novel packaging, served as the manufacturing liaison on product development/launch teams, and.

North Chicago, Illinios

Member of biological development pilot plant team that validated the facility and used mammalian cell culture to produce recombinant proteins, monoclonal antibodies, and vaccines that were used in clinical trials.

SVP Aseptic filling and component preparation supervisor.