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Senior Validation Engineer

2 months ago

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

Lonza is a global leader in life sciences, operating across three continents. We're seeking a Senior Process Validation Engineer to join our team in Houston, Texas.

Job Summary:

The Senior Process Validation Engineer will be responsible for planning, executing, and closing out Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities for Viral Vector and/or Cell Therapy processes. This role will ensure on-time and in-full delivery of associated tasks, activities, and documents.

Key Responsibilities:
  • Knowledge of regulatory requirements for biologics, including CGT space experience.
  • Manage, track, and report on readiness/execution status for PPQ/CPV activities and deliverables.
  • Responsible for Global Data Mart data verification, oversight, and generation of control charts and run charts for CPV reports.
  • Generate CPV reports at required reporting frequencies.
  • Serve as project lead for PPQ/CPV and point of contact between Client, Quality Control, Quality Assurance, Supply Chain, Manufacturing, Data Science, and/or Commercial Development Organization.
  • Work with other MSAT teams on complex problems of diverse scope.
  • Actively contribute to continuous improvement activities for applicable processes and deliverables.
  • Data Management, Generation of Process Validation/CPV documents.
  • Organize, manage, and interpret data, perform detailed data analysis.
  • Generate PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements.
Requirements:
  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, or other Life Sciences Degree.
  • 5+ years of experience/SME level of understanding with manufacturing/aseptic processes, process validation, PPQ, and CPV.
  • Extensive experience within cGMP regulated production environment.
  • CGT experience preferred.
  • Experience working with quality systems.
  • Ability to interface and communicate directly with clients.
  • Strong technical writing skills.

At Lonza, we respect and protect our people and our environment. We offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.