Senior Process Validation Engineer

Today, Lonza is a global leader in life sciences operating across three continents.

While we work in science, there’s no magic formula to how we do it.

Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people.

In exchange, we let our people own their careers.

Their ideas, big and small, genuinely improve the world.

And that’s the kind of work we want to be part of. 

 

Our Lonza site in Houston is seeking a Senior Process Validation Engineer.

The Sr Process Validation Engineer is responsible for the planning, execution and close-out of the PPQ/PV and/or CPV activities for Viral Vector and/or Cell Therapy processes to ensure on-time and in-full delivery of the associated tasks, activities and documents.

The individual in this role will also represent Lonza at client facing meetings and may provide guidance and support to other engineers on the team. 

 

Responsibilities:  



* Knowledge of regulatory requirements for biologics (experience in the CGT space is a plus), New Product Introduction and Process Lifecycle requirements and audit support skills. 


* Manages, tracks and reports 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. 


* Generates of CPV reports at the required reporting frequencies. 


* Serves as the project lead for PPQ / CPV and point of contact between Client, Quality Control, Quality Assurance, Supply Chain,  Manufacturing, Data Science, and/or the Commercial Development Organization, as required. 


* Works with other MSAT teams on complex problems of diverse scope where analysis of situation or data requires evaluation of process. 


* Actively contributes to continuous improvement activities for the applicable processes and deliverables within the organization.  


* Data Management, Generation of Process Validation/CPV documents. 


* Organizes, manages and interprets data, performs detailed data analysis.  


* Generates PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements.  


* Perform other duties as assigned and/or required based on business needs. 

 

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, Process Performance Qualification (PPQ) and Continued Process Verification (CPV). 


* Extensive experience within cGMP regulated production environment. 


* CGT (Cell and Gene Therapy) experience preferred. 


* Experience working with quality systems. 


* The ability to interface and communicate directly with clients will be required. 


* Strong technical writing...