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Halozyme, Inc Senior Engineer 2, Quality in Minnetonka, Minnesota

Senior Engineer 2, Quality

Welcome to an inspired career.

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. Thats why we need youto help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.

Join us as a Senior Engineer 2, Quality 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

As the Senior Engineer 2, Quality you will lead quality engineering activities for commercial products, including process validation, maintenance of DMR and risk management files, complaint risk analysis, and CAPA/SCAR/Deviation investigations. This position also participates in quality engineering activities for commercial scale up prior to product launch and supports internal and contract manufacturing. Through these activities, this position will also verify quality, reliability and compliance of mechanical product designs.

In this role, youll have the opportunity to:

  • Partner with manufacturing team to lead quality engineering activities with contract manufacturers (Process Validation, Change Management, Non-conformance resolution, deviations).
  • Lead CAPA/NCR/SCAR investigations and reports.
  • Maintain risk management files for commercial products via periodic review of risk documents, complaints and nonconformance trends.
  • Support DMR content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps.
  • Support manufacturing process development and qualification for product changes.
  • Maintain release testing plans and associated test methods and procedures.
  • Identify and lead continuous improvement projects.
  • Lead complaint investigations.

To succeed in this role, youll need:

  • Bachelor degree in Engineering (Mechanical, Material Science or Biomedical) or related Science with minimum of 8 years relevant experience within the medical device industry or related a combination of education and experience may be considered)
  • Experience in manufacturing processes for drug-device combination products related to development and commercial programs a plus.
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance.
  • Good statistical data analysis skills.
  • Experience with participation in audits.
  • Lead auditor certification preferred.
  • Six Sigma Belt preferred. ASQ certification a plus

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.

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.

The most likely base pay range for this position is $100K - $152K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individuals exact level of compensa ion. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

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 [hrbox@halozyme.com]{rel="noopener noreferrer" target="_blank"}.

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