• Job Description

  Req#: R0000975

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  Senior Engineer 2, Quality- This position is located in our Minnetonka, MN site.

  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. That’s why we need you—to 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 Senior Engineer 2, Quality 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

  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, the Senior Quality Engineer will verify quality, reliability and compliance of mechanical product designs.

  In this role, you’ll 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 & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for product changes
  • Maintains release testing plans and associated test methods and procedures
  • Identifies and leads continuous improvement projects
  • Supports internal & external audit
  • Lead complaint investigations, quality system improvements as required
  • Reviews supplier documentation in accordance with established requirements

  To succeed in this role, you’ll need:

  • BS degree in an engineering or physical/life science field with 8+ years relevant experience within the medical device industry or related function (a combination of education and experience may be considered). Background 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
  • Validation Experience highly preferred
  • Good statistical data analysis skills
  • Lead auditor certification preferred
  • Six Sigma Belt preferred
  • Ability to interface with internal customers, 3rd-party partners, and regulatory agencies
  • 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 impact—on 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 $108k - $150k per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s 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.

• About the company

  The company was founded in 1998 and went public in 2004.

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