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Steve Fix

Steve Fix

Validation medical and pharmaceutical

Talent
Irvine, Orange100 USD/hourMember since January 23, 2024
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pharmaceutical validation consultantsenior consultantvalidation engineering consultant

About

Dear Human Resources,

I have over ten years of pharmaceutical validation consulting experience working with a wide range of processes, and I offer a very unique background with a broad skill set for developing, qualifying, and implementing new technologies, services, and solutions for pharmaceutical clients.

I have a Master of Business Administration from the University of California, Irvine, graduating Cum Laude, Dean's Honor Graduate and Beta Gamma Sigma, National Honor Society, and a Bachelor of Science in Mechanical Engineering specializing in polymers and coatings from North Dakota State University, Fargo.

As a Senior Consultant I have been working with numerous pharmaceutical companies across a wide range of projects.

  • Aaron Industries: Developed plan for restoring and re-launching of Hydrogen Peroxide storage and bottling systems.
  • Illumina: Performed validation for cGMPs of DNA testing reagents.
  • Neutrogena: Implementation and validation of a plant wide clean-in-place system. 
  • Prolacta: Performed validations for fortifying human breast milk for NICU premature infants. 
I was also an expert witness for Nobel Biocare’s defense of dental implant intellectual property lawsuit. With my depositions, testimony, and expert analysis, Nobel Biocare was successful in defense of their intellectual property and the settlement of this lawsuit.
  • Co-Inventor of US Patent 5,795,160 Tapered Dental Implant in a Stepped Orifice. 
For the last four years I was a Senior Validation Engineering Consultant for Cryoport providing consulting services to leading Cell and Gene Advanced Therapy Pharmaceutical Companies such as Catalent, Encarta, Helix, Honeywell, In8bio, Iovance, Kite, Novartis, SanBio, Sarepta, SQZ, Tessa, and Vertex.

I have the technical experience to be a valuable addition to your team and I know I can contribute substantially to the continued success of your clients.

Sincerely,

Steven J. Fix

Experience

Dear Human Resources,

I have over ten years of pharmaceutical validation consulting experience working with a wide range of processes, and I offer a very unique background with a broad skill set for developing, qualifying, and implementing new technologies, services, and solutions for pharmaceutical clients.

I have a Master of Business Administration from the University of California, Irvine, graduating Cum Laude, Dean's Honor Graduate and Beta Gamma Sigma, National Honor Society, and a Bachelor of Science in Mechanical Engineering specializing in polymers and coatings from North Dakota State University, Fargo.

As a Senior Consultant I have been working with numerous pharmaceutical companies across a wide range of projects.

  • Aaron Industries: Developed plan for restoring and re-launching of Hydrogen Peroxide storage and bottling systems.
  • Illumina: Performed validation for cGMPs of DNA testing reagents.
  • Neutrogena: Implementation and validation of a plant wide clean-in-place system. 
  • Prolacta: Performed validations for fortifying human breast milk for NICU premature infants. 
I was also an expert witness for Nobel Biocare’s defense of dental implant intellectual property lawsuit. With my depositions, testimony, and expert analysis, Nobel Biocare was successful in defense of their intellectual property and the settlement of this lawsuit.
  • Co-Inventor of US Patent 5,795,160 Tapered Dental Implant in a Stepped Orifice. 
For the last four years I was a Senior Validation Engineering Consultant for Cryoport providing consulting services to leading Cell and Gene Advanced Therapy Pharmaceutical Companies such as Catalent, Encarta, Helix, Honeywell, In8bio, Iovance, Kite, Novartis, SanBio, Sarepta, SQZ, Tessa, and Vertex.

I have the technical experience to be a valuable addition to your team and I know I can contribute substantially to the continued success of your clients.

Sincerely,

Steven J. Fix

Education

MBA UC Irvine, CA

BSME NDSU Fargo, ND

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