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.