Senior MSAT Engineer (Biotech)
Job Description:
Today, Lonza is a global leader in life sciences operating across five 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 Manufacturing Sciences and Technology (MSAT) Senior Engineer – Small Molecule will be responsible for Technology Transfers from internal and external sources, Data Entry (process improvement), and Process Validation (process performance qualification) and support in commercialization.
Key Responsibilities:
Performs all MSAT functions associated with process transfer, batch record drafting and process support of small molecule
Perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary, perform activities for lot release (assess deviations and process changes), and continued process verification activities.
Provide guidance on process transfer and support activities to junior members of the team.
Assess all major deviations for impact product quality.
Authors / present training presentations to manufacturing and other departments.
Effectively work with other departments and interface with customers.
Engagement of internal and external technical teams to facilitate successful technical transfers of product processes
Directly involved with customers to ensure projects are planned and executed appropriately in order to deliver to and meet the needs of our customers and the business
Comply with all state and federal regulatory requirements and guidelines
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
Key Requirements:
Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering. Masters of Science or Engineering or PhD highly preferred.
Extensive industry experience in process scale up/manufacturing and process validation.
5 years Experience with Good Manufacturing Practice (GMP) and manufacturing support (Oral Solid Dose)
US/EU regulations and intermediate knowledge of statistical data analysis
Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
Able to concisely communicate status, needs, forecasts, risks and timelines effectively to senior management
Excellent attention to detail, with ability to prioritize and be flexible in managing change, anticipating and resolving complex technical and business problems with ability to positively impact customer relationships and external technical network
Displays a clear willingness to listen to others. Has good interpersonal skills and works collaboratively in an effective manner to achieve objectives.
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.
