Senior Process Validation Engineer

3 weeks ago


Alvin, Texas, United States Lonza Full time
Job Title: Senior Process Validation Engineer

Lonza is seeking a highly skilled Senior Process Validation Engineer to join our team in Houston, Texas. As a key member of our Process Validation team, you will be responsible for ensuring the quality and integrity of our biologics products.

Responsibilities:
  • Develop and execute process validation plans, protocols, and reports to ensure compliance with regulatory requirements.
  • Manage and track readiness/execution status for PPQ/CPV activities and deliverables.
  • Verify and generate control charts and run charts for CPV reports.
  • Generate CPV reports at required reporting frequencies.
  • Lead PPQ/CPV projects and serve as point of contact between Client, Quality Control, Quality Assurance, Supply Chain, Manufacturing, Data Science, and/or Commercial Development Organization.
  • Collaborate with MSAT teams to resolve complex problems and improve processes.
  • Contribute to continuous improvement activities and data management.
  • Organize and interpret data, perform detailed data analysis, and generate PPQ/PV and/or CPV documents.
Requirements:
  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, or other Life Sciences degree.
  • 5+ years of experience with manufacturing/aseptic processes, process validation, PPQ, and CPV.
  • Extensive experience in cGMP regulated production environment.
  • CGT experience preferred.
  • Strong technical writing skills and ability to interface with clients.

At Lonza, we value our employees and strive to create a positive and inclusive work environment. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for process validation, we encourage you to apply for this exciting opportunity.



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