Medical Device Validation SME

St. Louis, MO

Job ID: 126584 Industry: Pharma

Pharmaceutical Validation SME

Project Description:

Our client is a large pharmaceutical company who is converting their clinical site into a commercial manufacturing site for a solid oral dosage product. The client has 8 new pieces of equipment that need to be qualified and remediated.


Day-to-Day Responsibilities


The client is looking for a Validation SME with experience converting clinical sites into commercial solid dose manufacturing sites. This consultant will be performing a gap assessment for qualification of each piece of new equipment. They will then find which gaps need to be remediated and then remediate and validate the equipment. The consultant must have experience with facilities and utilities as well as doing gap assessments for facility conversions. The consultant must be a high energy person who will take the initiative and is comfortable doing the hands on technical writing as well. The consultant must have experience writing validation master plans and conducting gap assessments for a commercial site.  This will be the first steps in a large project initiative to convert this site. The consultant should have an understanding of qualification of solid dosage equipment at a very high level.


  • Validation Master Plans
  • Solid Oral Dosage Equipment Qualification
  • Blenders and Granulators
  • Fluid Bed Dryers
  • Tableting Compression

Job Type: Contract   

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