Validation Engineer

4 weeks ago

Parsippany, United States Insight Global Full time

Day to Day:

Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have experience developing validation protocols for various process equipment and systems. This individual will have to execute validation test according to established protocols (IQ, OQ,PQ).



Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

Must-Haves

  • 2+ years Validation specialist or engineer within Pharma or Biopharma
  • Experience executing and writing test protocols Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Comprehensive knowledge of production processes
  • Knowledge of CAPA's and Deviation Investigations
  • Experience with Trackwise or Veeva or a similar QMS

Below is a list of all the equipment this team works on:

  • Temperature Controlled Units – reach-in and walk-in units
  • Sterile filling isolator
  • Vaporized Hydrogen Peroxide Chambers / equipment with VHP cycles
  • Media Fills for freeze dried and liquid filled sterile vial processes
  • Utility commissioning – critical utilities – WFI, Pure Steam, Sterile Comp Air, Clean N2
  • HVAC commissioning
  • Single Use compounding systems
  • QC Analytical, Bioanalytical and QC Micro instrument qualification
  • Parts Autoclaves
  • Parts Washers
  • Packaging equipment (e.g. vial labelers, cartoners)

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