John Kohn Email and Phone Number
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Writes and executes facility, system, and equipment URS, DQ, IQ, OQ, and PQ qualifications, processing, packaging, and cleaning validations. Creates and updates MS Project timelines, budgets for facility expansion projects. Manages 4-6 validation contractors on yearly projects and mentors junior validation technicians and specialists.Project manager for large validation projects.
Tolmar
View- Website:
- tolmar.com
- Employees:
- 637
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Sr. Quality Assurance Validation EngineerTolmar Mar 2021 - PresentUnited States
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Validation Engineer 3Terumo Bct Jun 2019 - Mar 2021Lakewood, CoEtO Sterilization and Process Validation of medical devices. -
Senior Validation EngineerTolmar Sep 2016 - May 2019Fort Collins, Colorado AreaReceived 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
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Manager Product/Process DevelopmentPinnacle Transplant Technologies Dec 2015 - Sep 2016Phoenix, Arizona AreaManaged 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. -
Manager Quality CompliancePinnacle Transplant Technologies Jul 2014 - Dec 2015Phoenix, Arizona AreaPTT 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
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Validation Engineer IiiTeva Pharmaceuticals Aug 2013 - Jul 2014Phoenix, AzDrafted 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. -
Quality AssuranceTeva Pharmaceuticals 2012 - Aug 2013Phoenix, AzImplemented 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.
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Director Technical ServicesMedicis Mar 2005 - Aug 2012Scottsdale, Az -
Director Quality Assurance & Technical ServicesMedicis Mar 2005 - Sep 2007Scottsdale, Az
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Manager Technical Services & Project ManagementMedicis Feb 2002 - Mar 2005Scottsdale, Az
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Technical Project ManagerMedicis Mar 2000 - Feb 2002
John Kohn Skills
John Kohn Education Details
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Siebel Institute Of Technology3.9 -
Arizona State UniversityMicrobiology
Frequently Asked Questions about John Kohn
What company does John Kohn work for?
John Kohn works for Tolmar
What is John Kohn's role at the current company?
John Kohn's current role is Quality Assurance.
What is John Kohn's email address?
John Kohn's email address is jk****@****ant.com
What is John Kohn's direct phone number?
John Kohn's direct phone number is +148038*****
What schools did John Kohn attend?
John Kohn attended Siebel Institute Of Technology, Arizona State University.
What skills is John Kohn known for?
John Kohn has skills like Manufacturing, Project Management, Gmp, Quality Assurance, Continuous Improvement, Cross Functional Team Leadership, Change Control, Quality System, Trackwise, Ms Project, Leadership, Technology Transfer.
Who are John Kohn's colleagues?
John Kohn's colleagues are Juliet Henry, Ruben Marquez, Tyler Boschman, Duane Collins, Jackie Lagasse, Scott Smith, Heifa Elmathkor.
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