Cell and Gene Therapy Process Validation Lead

1 week ago


Mont Belvieu, Texas, United States CV Library Full time

At CV Library, we're seeking a highly skilled Senior Engineer, Cell and Gene Therapy to lead our process validation efforts. This exciting role will be based in the United States, Houston (Texas), and will play a key part in ensuring the highest quality standards are met for our Viral Vector and/or Cell Therapy processes.

About the Role

The Senior Process Validation Engineer is responsible for the planning, execution, and close-out of PPQ/PV and/or CPV activities to ensure timely delivery of associated tasks, activities, and documents. As a representative of Lonza at client-facing meetings, you'll also provide guidance and support to other engineers on the team.

Key Responsibilities
  • Manage regulatory requirements for biologics, with experience in the CGT space preferred.
  • Lead Global Data Mart data verification, oversight, and control charts and run charts for CPV reports.
  • Generate CPV reports at required reporting frequencies.
  • Serve as project lead for PPQ/CPU and point of contact between Client, Quality Control, Quality Assurance, Supply Chain, Manufacturing, Data Science, and/or Commercial Development Organization.
  • Collaborate with MSAT teams on complex problems requiring evaluation of process.
Requirements
  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, or other Life Sciences Degree.
  • 5+ years of experience/SME level understanding with manufacturing/aseptic processes, process validation, PPQ, and CPV.
  • Extensive experience within cGMP regulated production environment.
  • CGT experience preferred.
  • Ability to interface and communicate directly with clients.
  • Strong technical writing skills.
Salary Information

We offer a competitive salary range of $110,000 - $140,000 per annum, depending on experience.

As a valued member of our team, you'll enjoy a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.



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