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Validation Specialist for Suite CD Chrom & VS Skids

Job Post Index 1F2532-Sy##
Location Andover, MA
Description: Description
  • Seeking a Validation specialist to develop a robust design suitable for use with a variety of production processes.
  • These assets will be designed for fully automated chromatography or filtration processing while connected to a DeltaV central control system.
  • The skids shall be cleanable using local CIP resources in the suite, and where possible, the existing facility centralized CIP systems.
  • The VS skid will also have an SIP process.
  • Work with senior validation engineer on commissioning and validation of process purification skids; chromatography, viral filtration
  • Prepare and/or complete qualification pre-requisite tasks, and follow up.
  • Protocol IQ/OQ, CIP OQ, SIP PQ development and pre-approval
  • Protocol IQ/OQ, CIP OQ, SIP PQ execution, deviation resolution, and QAV post approval
  • Commissioning/SAT execution and/or assistance
  • Protocol IQ/OQ, CIP OQ, SIP PQ summary reports and effective status in PDOCS
  • Work with Production to familiarize them with equipment & develop SOPs
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