• Full Time
  • Bend, OR
  • Dec 31, 2022

Website Lonza

Lonza Pharma & Biotech has an opening for an experienced Engineer, 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.

 

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 (Manufacturing Sciences and Technology) 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 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
Key Requirements:

Bachelor’s Degree
Intermediate understanding of cGMP regulations and manufacturing processes
Experience with Technology Transfer
Experience in pharmaceutical or related industry

To apply for this job please visit lonza.wd3.myworkdayjobs.com.