Senior Engineer 2, Process Development

Halozyme, Inc. • Minnetonka, MN

2d

About The Position

At Halozyme, we’re proud of what we do, and we continue to do more. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission. Join us as a Senior Engineer 2, Process Development and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives. How you will make an impact The Senior Engineer 2, Process Development designs, develops, implements, and maintains processes and equipment used to manufacture existing products and products in development, Products include, but are not limited to, combination pharmaceutical/medical devices used for self-injection. Processes include, but are not limited to, mid to high volume complex assembly, packaging, and labeling. In this role, you’ll have the opportunity to: Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product design Identify and recommend best-in-class manufacturing equipment and process technologies used within the medical device/pharmaceutical industry Design and develop manufacturing processes, equipment, and tooling that are lean and mistake-proof Develop equipment requirements specifications and work with suppliers to quote, procure, and implement into manufacturing Develop process validation plans, lead the execution of plans, and document results in reports Lead cross-functional teams to develop pFMEA’s and other risk assessments and implement effective manufacturing controls, managing project plans and schedules Collaborate with Operations team to develop effective process work instructions Implement equipment calibration and maintenance plans/schedules Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions Develop and validate test methods used in manufacturing Lead CAPA projects and problem-solving efforts

Requirements

• Bachelor’s degree in Engineering or related technical field with at least 8 years in process development or manufacturing (An equivalent combination of experience and education may be considered)

Nice To Haves

• Experience in medical device, pharmaceutical, GMP, or regulated industry preferred
• Experience with process validation (IQ/OQ/PQ) preferred
• Experience with design and troubleshooting automated equipment preferred
• Six Sigma Black Belt preferred
• Proficient in the use of Minitab, MS Project, and SolidWorks preferred
• Experience with Lean principles and metrics, problem solving methodologies, DMAIC, SPC, process capability analysis

Responsibilities

• Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product design
• Identify and recommend best-in-class manufacturing equipment and process technologies used within the medical device/pharmaceutical industry
• Design and develop manufacturing processes, equipment, and tooling that are lean and mistake-proof
• Develop equipment requirements specifications and work with suppliers to quote, procure, and implement into manufacturing
• Develop process validation plans, lead the execution of plans, and document results in reports
• Lead cross-functional teams to develop pFMEA’s and other risk assessments and implement effective manufacturing controls, managing project plans and schedules
• Collaborate with Operations team to develop effective process work instructions
• Implement equipment calibration and maintenance plans/schedules
• Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions
• Develop and validate test methods used in manufacturing
• Lead CAPA projects and problem-solving efforts

Benefits

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level