Cleaning Validation Engineer

Intellectt Inc
Danvers, MA

Job Title: Cleaning Validation Engineer

Location: Danvers, MA


We are seeking a Cleaning Validation Engineer to support a New Product Introduction (NPI) project focused on facility upgrades and tech transfer for biopharma manufacturing.

Key Responsibilities:

  • Lead CIP/SIP validation activities for NPI projects
  • Develop and optimize cleaning cycles for bioreactors, process piping, and transfer panels
  • Perform rinse/swab sampling and visual inspections
  • Execute riboflavin studies and autoclave/load pattern development
  • Support cleaning validation for washers and sterilization systems
  • Collaborate with cross-functional teams to ensure compliance and successful product transfer

Required:

  • 5+ years of Cleaning Validation experience
  • Hands-on experience with sampling (swab/rinse) and inspection
  • Strong experience with CIP/SIP cycle development
  • Experience with DeltaV automation
  • Knowledge of GMP and regulated environments

Nice to Have:

  • Experience with Ellab ValSuite Pro
  • Experience with ValGenesis (protocol development & execution)

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