Material Qualifications Principal Engineer
Los Angeles, CA
Req ID 47419BR
Business Title
Material Qualifications Principal Engineer
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
1st
Job Description
Summary
Displays standard principles to advise on Material Qualification and Supplier selection from conception to final design with team input. Plans, schedules and leads project assignments in the evaluation, selection, and qualification of materials with minimal guidance. Evaluate projects related to Material selection on conformity to USP/EP criteria and appropriate Process Validation and Product compatibility.
Essential Duties and Responsibilities
• Leads Material Qualification continuous improvement activities through protocol preparation, execution and final reports for a biologics operation. Writes and executes material qualification protocols and works with internal and external laboratories to fulfill requirements.
• Manages and works with team on extractables and leachables studies on raw materials used to manufacture product.
• With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project. This includes constructing detailed, accurate project schedules, interfacing with development groups, testing laboratories, and Supplier Quality on assessment of Supplier Changes.
• Ability to prioritize multiple tasks.
• May supervise/coordinate an engineer and/or technician on assigned work.
• Good analytical skills and data analysis.
• Management of Change Documents and Part Specifications to support project completion. Assists in maintenance of site Material Qualification Validation Plan with annual updates.
Job Requirements
• Familiar with USP/EP/JP criteria for conformity; familiar with FDA, EMA and JP regulations for material qualification and supplier selection.
• Must have strong technical background and familiarity with chemicals and raw materials.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Effectively operate in and may facilitate cross-functional teams with guidance.
• Must be able to provide solutions that reflect understanding business objectives and cost implications .
• Extensive hands-on troubleshooting while working closely with manufacturing personnel. Must have training in concepts of ""Six Sigma"" techniques.
• Experience in laboratory, pilot plant or production scale unit operations required.
• Strong organizational skills and be able to multitask effectively.
• Train team members and other department members on primary area of expertise
• Must be able work alone, as part of a team or leading a team in an efficient way.
Education and/or experience
• B.S. and 5 - 8 years related experience, or M.S. and 2- 4 years related experience.
• Ph.D. 1 - 2 years experience.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
