Senior Process Validation Engineer

Lonza - Houston, TX

Full-time - Mid Level

Houston, TX

Professional, Scientific, and Technical Services

About the position

The Senior Process Validation Engineer at Lonza's Houston site plays a crucial role in the planning, execution, and close-out of Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities specifically for Viral Vector and Cell Therapy processes. This position is essential to ensure that all associated tasks, activities, and documentation are delivered on time and in full. The engineer will also represent Lonza in client-facing meetings, providing guidance and support to other engineers on the team. In this role, the engineer will need to possess a strong knowledge of regulatory requirements for biologics, particularly in the context of New Product Introduction and Process Lifecycle requirements. The individual will manage, track, and report on the readiness and execution status of PPQ and CPV activities and deliverables. This includes overseeing Global Data Mart data verification and generating control charts and run charts for CPV reports. The engineer will be responsible for generating CPV reports at the required reporting frequencies and will serve as the project lead for PPQ and CPV, acting as the primary point of contact between clients and various internal departments such as Quality Control, Quality Assurance, Supply Chain, Manufacturing, Data Science, and the Commercial Development Organization. The Senior Process Validation Engineer will also collaborate with other teams to address complex problems that require thorough analysis of processes and data. Continuous improvement activities for applicable processes and deliverables will be a key focus, alongside data management and the generation of Process Validation and CPV documents. The engineer will be tasked with organizing, managing, and interpreting data, performing detailed data analysis, and generating necessary documentation according to established timelines and commitments. Additionally, the engineer may be required to perform other duties as assigned based on business needs.

Responsibilities

• Plan, execute, and close-out PPQ/PV and/or CPV activities for Viral Vector and/or Cell Therapy processes.
• Manage, track, and report on readiness/execution status for PPQ/CPV activities and deliverables.
• Oversee Global Data Mart data verification and generate control charts and run charts for CPV reports.
• Generate CPV reports at the required reporting frequencies.
• Serve as the project lead for PPQ/CPV and act as the point of contact between Client, Quality Control, Quality Assurance, Supply Chain, Manufacturing, Data Science, and/or the Commercial Development Organization.
• Collaborate with other MSAT teams on complex problems requiring evaluation of processes.
• Contribute to continuous improvement activities for applicable processes and deliverables.
• Manage data and generate Process Validation/CPV documents.
• Organize, manage, and interpret data, performing detailed data analysis.
• Generate PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments.

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 within a cGMP regulated production environment.
• CGT (Cell and Gene Therapy) experience preferred.
• Experience working with quality systems.
• Ability to interface and communicate directly with clients.
• Strong technical writing skills.