Job Title: Sr. Validation Engineer

Location: Alameda, California,

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.