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Validation Engineer

Intellectt Inc
Irvine, CA Full Time
POSTED ON 1/11/2025
AVAILABLE BEFORE 4/10/2025

Job Title : Sr. Validation Engineer-Onsite

Location : Irvine, California,(Only on w2)

Job Description :

  • We are seeking a Sr. Validation Engineer with over 8 years of experience in quality investigations. The ideal candidate will have the following qualifications
  • Key Responsibilities :
  • Lead and manage validation activities, focusing on quality investigations.
  • Perform Commissioning, Qualification, and Validation (CQV) in sterile / aseptic facilities.
  • Conduct thermal mapping and analyze results to ensure compliance with regulatory standards.
  • Collaborate with cross-functional teams to address and resolve any issues related to sterilization and SIP (Steam-in-Place).

Qualifications :

  • Minimum of 8 years of experience in quality investigations within a regulated environment.
  • Proven experience in CQV for sterile / aseptic facilities is essential.
  • Extensive experience in thermal mapping is required.
  • Sterilization and SIP experience is a plus.
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