Senior Validation Engineer
N/A
Los Angeles, CA, USA

Senior Validation Engineer (Contract)

Location: Los Angeles, CA

Role Overview

  • We're seeking a highly skilled Senior Validation Engineer. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documentation and validation tasks for automation projects. You'll also draft design specifications, conduct validation testing, and collaborate with various internal departments and external vendors to ensure smooth project execution.

Key Responsibilities

  • Draft and review documentation, including user requirements, design specifications, and testing protocols.
  • Conduct hands-on validation for automation projects and address protocol discrepancies.
  • Work with internal departments and external vendors to establish schedules and coordinate validation activities.
  • Attend project meetings and communicate status updates to relevant stakeholders.
  • Perform project management tasks and escalate issues to leadership as needed.

Qualifications

  • Bachelor's Degree and a minimum of 5 years of experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, or cell therapy industries.
  • Strong knowledge of equipment and computerized systems, with an understanding of data integrity and change control management.
  • Excellent interpersonal and technical writing skills.
  • Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems is preferred.
  • Proficiency in Microsoft Office tools, including PowerPoint, MS Project, Excel, and Word.
  • Ability to work collaboratively across departments and with external vendors.
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