Process Validation Senior Engineer
Today Lonza is a global leader in life sciences. 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.
The Process Validation Sr. 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.
- PPQ and/or CPV Subject Matter Expert
- 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.
- Bachelor’s degree with relevant, extensive experience in life sciences or related field, or Master’s degree with advanced experience in life sciences, preferred.
- Advanced experience (5+ years) in Viral Vectors/Cell Therapy/Biologics PPQ/PV/CPV, Technology Transfer, MSAT and/or Manufacturing is preferred.
- Knowledge of statistics
- Understanding of large-scale biotechnology unit operations and GMP requirements
- Knowledge of aseptic techniques
- Strong computer skills (including Word, Excel, Outlook and PowerPoint.), data analysis;
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
- Present information and ideas effectively, formally and informally, verbally and in writing to others in a manner that facilitates understanding.
- Displays a clear willingness to listen to others. Has good interpersonal skills and works interdepartmentally in an effective manner to achieve objectives
- Shows commitment and dedication and strives to be ahead of schedule.
- Demonstrates ability to find creative solutions to issues and obstacles.
- Practices safety awareness at all times and considers impact of actions prior to executing activities.
- Demonstrates critical thinking skills in problem-solving and decision making
- Attention to details and high level of accuracy
- The capacity to motivate and encourage others, in the achievement of specific objectives, and to carry ultimate responsibility.
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.