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.
Lonza Walkersville has an exciting opening for an MSAT Engineer/Scientist who will play a crucial role in Bioscience by leading Tech Transfers, complex technical investigations, process improvements. This individual is the key process knowledge holder who drives the proactive life-cycle management through continuous and systematic optimization of production processes. The MSAT Engineer/Scientist is responsible for the incremental improvement of a process, but also ensures excellent process understanding and process robustness. As well as provides technical expertise in process risk assessment, technical complex investigations, CAPA management. Acts as a Subject Matter Expert in any of the following unit operations: Aseptic processing, cell culture, mixing, filtration/filling/finishing.
- As a Tech Transfer leader, ensures that new products are introduced in our cGMP facility meeting Regulatory/Business expectations
- Performs Process Fit Gap analysis using risk analysis tools such as pFMEA and authoring Facility Fit Gap Analysis Reports
- Manages New Product Introduction Change Control and authors Process Description Reports and supports process validation activities as needed.
- Leads the receiving team workstream and is accountable for tech transfer milestones to commercial.
- While supporting complex technical investigations, the MSAT Engineer/Scientist uses root cause analysis tools such as Causal Branching, Fault Tree Analysis, Event and Causal Factor Charting and Defense Analysis
- Authors technical reports and use Quality Systems tools such as TrackWise and Document Management Systems (DMS) to document investigations and technical studies.
- Manages Deviations/CAPAs following Lonza’s SOPs and Quality Systems tools and acts as SME during internal and External audits.
- While continuous monitoring of GMP processes, the Process Engineer/Scientist uses statistical analysis to identify opportunities for improvement such as reduce process variability, streamlined manufacturing processes, increase efficiency.
- Drives the implementation of the elaborated improvements on commercial scale to raise profitability and to achieve sustainable business success while fostering good customer relationship with stakeholders.
- Accountable for project results by planning, monitoring and managing projects/lab programs from initiation through completion.
- Collects, summarizes, analyzes data to prepare reports and makes presentations, as appropriate, to disseminate best practice throughout the function.
- Supports FATs/SATs activities including IQ/OQ/PQ of new equipment by providing process knowledge expertise to the team.
- Bachelor’s degree in Chemical Engineer or related discipline; Master’s degree or PhD preferred
- Experience with Process Improvements and Aseptic processing
- Experience with Tech Transfer/Cell Culture
- Excellent Technical with compliance minded writing skills
- Excellent oral communication skills
- Able to translate opportunities into workable solutions
- Strong analytical and problem solving skills coupled with the ability to work both independently and in a team environment
- High attention to detail
- Demonstrates strong business awareness
- Leadership: ability to lead and influence team and stakeholders
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.