0020V Lead Cleaning Validation Engineer

Two River Consulting PartnersDevens, MA
6dOnsite

About The Position

The New Product Introduction (NPI) project aims to implement facility modifications for the tech transfer of one or more new products into the LSCC as well as further improvements that may be used to drive future enhancements in manufacturing throughput. The selected candidate will lead the CIP / SIP portion of the NPI project.

Requirements

  • 7-10 years of relevant Validation Experience within pharma / biologics.
  • Minimum 5 years of Cleaning Validation experience to include:
  • Hands-on experience taking rinse and swab samples and performing visual inspection.
  • Experience developing CIP and SIP cycles for process piping, transfer panels, and bioreactors.
  • Experience developing load patterns for autoclaves and parts / glass washers.
  • Experience with Delta V automation for CIP / SIP.
  • Hands on experience executing Riboflavin studies.

Nice To Haves

  • Experience using Ellab ValSuite Pro system
  • Experience using Valgenesis for electronic development/review of protocols and execution.
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