MSAT Engineer II

Lonza Group Ltd. • Full-time • Sunriver, OR, Deschutes County, OR, US • 1d ago

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 lies in the collaboration of versatile individuals, brainstorming ideas that enable businesses to positively impact society. In exchange, we empower our employees to take ownership of their career paths. Their innovative ideas, both significant and subtle, truly transform the world. And that’s the kind of work we strive to be a part of. Lonza Pharma & Biotech has an opening for an experienced Engineer II, MSAT in their Bend, OR location. Responsible for BRI-M technical operations and providing deep scientific and technical insight to the manufacturing operation. Serves as the primary process owner for commercial products, ensuring that the process is capable of reliably delivering safe and efficacious product to patients. Key Responsibilities: 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 for certain activities, such as spray drying or solid dosage form manufacturing across the site. Supports Pre-Approval Inspection (PAI) or other regulatory audits as an expert in product and process subject matter. 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 offers mentorship 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. Key Requirements: Bachelor’s Degree. Intermediate understanding of cGMP regulations and manufacturing processes. Experience in pharmaceutical or related industry. J-18808-Ljbffr