John Kohn Email & Phone Number

United States

Lakewood, Co

EtO Sterilization and Process Validation of medical devices.

Fort Collins, Colorado Area

Received Technical Operations "Over the TOPC Performer" award in February 2018.Received recognition of outstanding support for new product launches and technical transfers from Process Development and Technical Services departments in 2017. Privileged to manage and lead 3 separate groups of validation contractors in qualifying over 85 new pieces of equipment for new facility at the Cornerstone facility in 22 months. Drafts and executes facility, system, and equipment (FSEs) URSs… Show more Received Technical Operations "Over the TOPC Performer" award in February 2018.Received recognition of outstanding support for new product launches and technical transfers from Process Development and Technical Services departments in 2017. Privileged to manage and lead 3 separate groups of validation contractors in qualifying over 85 new pieces of equipment for new facility at the Cornerstone facility in 22 months. Drafts and executes facility, system, and equipment (FSEs) URSs, DQs, Validation Plans, IQ, OQ, and PQ protocols and reports, review process, packaging, and cleaning validations protocols and reports. Create and update MS Project timelines (MS Project & SmartSheets), create and update validation contractor budgets for facility expansion projects. Managed up to six validation contractors and mentor junior validation technicians and specialists. Show less

Phoenix, Arizona Area

Managed Product/Process Development Department: provided leadership and project management to team of talented associates who performed equipment qualifications, calibrations, late stage product and package development, processing and packaging validation, environmental monitoring, preventive maintenance, training to GMPs, GTPs, and safety compliance to FDA and AATB regulations.

Phoenix, Arizona Area

PTT Associate of the month award in April 2015PTT 2015 Associate of the Year in December 2015Completed 10-month "Leadership for the Future" Training October 2015 and was selected as one of several new trainers for the next generation of leadership candidates for 2016.Performed internal audits of calibration, qualification, and PM systems, enhanced the EM program and implemented changes to EM program which reduced sampling errors and contract testing costs by approximately… Show more PTT Associate of the month award in April 2015PTT 2015 Associate of the Year in December 2015Completed 10-month "Leadership for the Future" Training October 2015 and was selected as one of several new trainers for the next generation of leadership candidates for 2016.Performed internal audits of calibration, qualification, and PM systems, enhanced the EM program and implemented changes to EM program which reduced sampling errors and contract testing costs by approximately $200,000/year. Managed the Document Control system, implemented improvements to sterile barrier laminate packaging to improve product stability, and participated in regulatory and customer audits. Show less

Phoenix, Az

Drafted and executed IQ/OQ protocols and reports for various equipment and utilities, wrote and executed PV protocols and reports for high-speed sachet filling and packaging line, performed in-process QC inspection and testing per approved TMs, as well as for capsule filling, and packaging equipment.

Phoenix, Az

Implemented a first ever EDMS system (Glorya) at the site, ahead of plan, prepared all training materials for users, reviewers & approvers, and system administrators, prepared all documents and document metadata spreadsheets for transfer into new system, held over 38 training sessions for all users, reviewers, approvers and system administrators.

Scottsdale, Az

Scottsdale, Az

Scottsdale, Az

Associates In Brewing Technology, 3.9

Bachelor Of Science, Microbiology

Activities and Societies: Worked 32-40/week to put myself through college. Lab Assistant Scientist - worked on Valley Fever research.