Senior MSAT Engineer

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 Senior MSAT Engineer 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 transfer standard and non-standard processes to manufacturing suites or support commercial campaigns for customers or products.
• Represent MSAT (Manufacturing Sciences and Technology) in project teams and communicate directly with customers. Recognized as subject matter expert for certain activities, such as spray drying or solid dosage form manufacturing across the site.
• Support Pre-Approval Inspection (PAI or equivalent experience) or other regulatory audits as product and process subject matter expert.
• Independently assess 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.
• Perform or understand all types of complex data analysis, such as statistical process control, multiple linear regression analysis, ANOVA, and multivariate analysis.
• Lead 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.
• Author and review documentation such as User Requirement Specifications, Process Flow Diagrams, and Study Protocols. Develop process models and provide mentorship on engineering projects.
• Lead process performance qualification (PPQ) and continuous process verification (CPV) activities for commercial products.
• Support the development of start-up and commissioning plans in conjunction with engineering and validation.
• Support the manufacturing team with development of training curriculum for operators.
• Other responsibilities as required.

• Bachelor’s Degree or equivalent experience in Engineering or related field.
• Proven understanding of cGMP regulations and manufacturing processes.
• Experience with Technology Transfer.
• Demonstrated experience in the pharmaceutical or related industry.
• Outstanding problem-solving skills and the ability to successfully implement solutions.
• Strong communication and collaboration skills to work effectively within a diverse team.
• Ambitious and driven to compete in a world-class environment.
• Ability to strictly adhere to protocols and identify the standard methodologies for flawless implementation.
• Willingness to support continuous improvement initiatives and strive for operational excellence.

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.