Expert in Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance
Project Manager on a $6 million project to specify, procure, install and commission numerous pieces of process and facility equipment for a medical device manufacturer.Project Engineer/Manager on a $9 million project to renovate and construct facility to accept 6 new high speed tablet presses.
Inspection and review of a manufacturing facility to make recommendations to bring it into FDA and EU regulatory compliance in advance of commissioning and validation.
Assisted in writing procedures, validation protocols, reports and other documents associated with media fills for a new aseptic process.
Designed, sourced equipment, managed contractors, wrote procedures, and commissioned an operational cleanroom for mixing and filling an aseptic liquid product.
Expert may consult nationally and internationally, and is also local to the following cities: Denver, Colorado - Colorado Springs, Colorado - Aurora, Colorado - Fort Collins, Colorado - Arvada, Colorado - Westminster, Colorado - Boulder, Colorado - Greeley, Colorado - Longmont, Colorado - Cheyenne, Wyoming
|Year: 1984||Degree: BS||Subject: Mechanical Engineering||Institution: Grove City College|
|Year: 1995||Degree: MA||Subject: Organizational Management||Institution: University of Phoenix|
|Years: 2008 to 2012||Employer: OpSolutions Inc.||Title: Owner||Department:||Responsibilities: He consults to pharmaceutical, biotech, and medical device companies on operations and facilities issues including manufacturing, maintenance, process engineering, construction and cGMP compliance.|
|Years: 2002 to 2008||Employer: TOLMAR Inc.||Title: Vice President of Manufacturing||Department:||Responsibilities: He provided leadership for all aspects of technical operations including manufacturing, logistics, warehouse, IT, process and packaging engineering, and facilities.|
|Years: 2001 to 2002||Employer: Facility Solutions||Title: Director, Project Services||Department:||Responsibilities: He oversaw the management and performance of all operational aspects of a full service facilities outsourcing firm including, project management, planning and design, move management, and facilities services.|
|Years: 2000 to 2001||Employer: Gambro BCT||Title: Facilities Site Manager||Department:||Responsibilities: He managed all capital projects for a medical device manufacturing company including clean rooms, warehouse, site projects and offices. He developed plans from concept stage, assigned project management resources to complete construction. He assisted in long -range planning for site to ensure optimum utilization of assets.|
|Associations / Societies|
|Licenses / Certifications|
|Certified Plant Engineer|