Process Engineer I (Biotech)
Join Lonza AG as a Process Engineer and become part of an exceptionally skilled team committed to innovation and excellence. This outstanding opportunity allows you to take the lead in technical support for our world-class manufacturing processes. You will become integral in supporting and optimizing one to three manufacturing processes while assisting with process transfer activities. As a subject matter expert in your field, you are going to be pivotal in ensuring flawless execution and resolving issues with your validated expertise. Your role will involve collaborating with various teams to drive ambitious projects to successful completion.
Key Responsibilities:
Successfully implement process transfer and support activities, develop comprehensive process understanding, perform gap analysis and FMEA, generate process models, and author/review process descriptions and batch records. You will also author/review planned deviations and change controls, monitor processes (summarize and analyze manufacturing data, present data), and author campaign summary reports. Additionally, perform activities for lot release by assessing deviations and process changes.
Spot and evaluate small deviations, determine potential causes, and analyze data to identify out-of-control trends and shifts. Perform simple linear regression analyses to guarantee product quality.
Independently author and review process descriptions, definitive formulations, batch records, and raw material listings. Assess the impact of changes to processes, equipment, or procedures and support documentation preparation for regulatory purposes.
Work with project teams, engage with customer technical and quality representatives, and contribute to internal teams such as Deviation and Run Daily Management System meetings. Moreover, you will participate in customer audits, highlighting our outstanding capabilities.
Follow all training and policy guidelines established for the facility, including cGMP requirements. Stay on top of your training profile by monitoring training lists (e.g., ComplianceWire, SAP Learning Portal) and promptly finishing all required training.
Perform other duties as assigned, giving to the overall success of the team.
Key Requirements:
Bachelor of Science degree in Biotechnology, Biological Sciences, or Chemical Engineering.
Proven experience in biotech, process development, process scale-up, tech transfer, or manufacturing. Experience with large-scale (2 kL +) manufacturing support for mammalian processes is preferred.
Solid understanding of cell biology, protein structure, scale-up processes, chromatography, ultrafiltration, defiltration, and virus filtration.
Outstanding communication skills, both verbal and written, with the ability to clearly express ideas and viewpoints. Strong social skills, demonstrating commitment, dedication, and the determination to stay ahead of schedule.
Values safety and takes into account the consequences of actions before driving activities.
Ability to share 24/7 on-call support while the process is being manufactured.
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 dedicated individuals working together, generating innovative ideas that support businesses in making a positive impact on society. In return, we empower team members to take ownership of their careers. Their ideas, whether big or small, truly make a difference in the world. And that's the type of work we strive to contribute to.
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 happiness that comes with improving lives all around the world. The happiness 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.
