Process Engineer II
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.
The Process Engineer II ensures that all GMP Manufacturing processes are designed and executed in a compliant and efficient manner. The Process Engineer II is involved with the technical and regulatory aspects of all assigned projects from inception to completion. The Process Engineer II works cross-functionally within the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Lonza.
- Provide technical support to all GMP Manufacturing processes and projects
- Develop manufacturing processes in conjunction with internal Formulation Development group, client or combination thereof, to enhance and improve the manufacture of GMP drug products.
- Write Master Batch Records and review executed batch records
- Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required
- Recommend, specify and order GMP manufacturing equipment which includes setup, qualification, writing and execution of qualification protocols
- Process validation of commercial manufacturing processes including writing, review and execution of process validation protocols
- Participate in project scheduling (including daily, short term, and long term) activities along with all applicable departments
- Provide input for forecasting of budget requirements and help to manage department expenses
- Maintain a positive, professional and confidential relationship with sponsors
- Comply with all state and federal regulatory requirements and guidelines
- Formulate and coordinate program specifications, requirements for proposals and contracts and associated documents
- Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
- Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
- Stop work where deemed necessary to maintain safety
- Bachelor’s degree in science or engineering required
- Significant experience in a pharma GMP setting
- Intermediate experience in MS office ( ie. minitab, trackwise)
- Solid technical writing experience ( protocols, batch records, reports)
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.