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. Responsibi... more details
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, executionand 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, activitiesand documents. The individual in this role will also representLonza 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 skills.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, 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.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
Welcome to Job Abstracts
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.