Engineer III, MSAT
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 Pharma & Biotech has an opening for an experienced Engineer III, MSAT at their Bend, OR location. This candidate will be responsible for BRI-M technical operations and providing deep scientific and technical insight to the manufacturing operation. They will serve as the primary process owner for commercial products, ensuring that the process is capable of reliably delivering safe and efficacious product to patients.
- Understand and apply chemical and engineering fundamentals including chemistry, materials science, heat and mass transfer, fluid mechanics, thermodynamics, conservation of mass and energy, and basic mathematical modeling
- Independently transfers standard and non-standard processes to manufacturing suites or supports commercial campaigns for customers or products
- Represents MSAT in project teams and communicates directly with customers. Recognized as subject matter expert in solid dosage form manufacturing across the site.
- Supports Pre-Approval Inspection (PAI) or other client and regulatory audits as product and process subject matter expert
- Independently assesses impact of changes to the product, process, equipment, procedures, or materials
- Drive Operational Excellence by identifying projects to improve yield, lower costs, and improve efficiency
- Performs or is able to understand all types of complex data analysis, such as statistical process control, multiple linear regression analysis, ANOVA, and multivariate analysis
- Leads process and/or technical-related investigations to support root cause analysis, product impact assessment, and effective Corrective Action and Preventative Action definition
- Use risk management methodology and tools to drive reliable product quality and supply
- Assess operational safety by evaluating engineering controls and procedures used in the manufacturing equipment and process
- Authors and reviews documentation such as User Requirement Specifications, Process Flow Diagrams, and Study Protocols. Develops process models and provides guidance on engineering projects
- Lead process performance qualification (PPQ) and continuous process verification (CPV) activities for commercial products
- Supports development of start-up and commissioning plans in conjunction with engineering and validation
- Support manufacturing team with development of training curriculum for operators
- Other responsibilities as required
- Bachelor’s Degree
- Understanding of cGMP regulations and manufacturing processes
- Experience with Technology Transfer
- Experience in pharmaceutical or related industry
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.