Senior Engineer 2, Process Development
Minnetonka, MN - USA
Job Summary
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We look forward to discovering your talents.
Welcome to an inspired career.
At Halozyme were proud of what we do and we continue to do more. Thats why we need youto 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 youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples 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 youll 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 pFMEAs 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
To succeed in this role youll need:
Bachelors 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)
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
In return we offer you:
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 impacton your career the work you do and patients lives.
The most likely base pay range for this position is $116k - $162k per year. Several factors such as experience tenure skills and particular business needs will determine an individuals exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses sales incentives and equity awards.
Halozyme Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race color religion sex sexual orientation gender identity national origin age protected veteran or disabled status or genetic information.
AccessibilityandReasonableAccommodations:
Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability contact Human Resources at .
To view all our open positions please visit our career page. Additionally our benefit offerings can be found here.
Required Experience:
Senior IC