Expert Details

Expert in Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance

Expert ID: 725448 Colorado, USA

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In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance, and facilities compliance. During one facility audit as a consultant, he discovered an annual savings in the facilities department of one client of approximately $650,000 per year. As VP of Manufacturing for a mid size pharmaceutical manufacturing company, the expert successfully completed over 2 dozen audits of the facility including FDA, ISO, and EU.

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

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Education

Year Degree Subject Institution
Year: 1984 Degree: BS Subject: Mechanical Engineering Institution: Grove City College
Year: 1995 Degree: MA Subject: Organizational Management Institution: University of Phoenix

Work History

Years Employer Title Department Responsibilities
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.

Career Accomplishments

Associations / Societies
PDA, ISPE
Licenses / Certifications
Certified Plant Engineer

Fields of Expertise

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