Engineer 2, Quality

Antares Pharma • Hopkins, MN

222d • $71,000 - $100,000

About The Position

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 an 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.

Requirements

• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science with minimum of 3 years relevant experience within the medical device industry or related function.
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance.
• Experience with participation in audits.
• Validation Experience highly preferred.
• Lead auditor certification preferred.
• Design for Six Sigma and Critical to Quality training and experience a plus.
• ASQ certification a plus.
• Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus.

Responsibilities

• 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.
• Participate in quality engineering activities for commercial scale up prior to product launch.
• Evaluate mechanical product design and identify potential design quality issues and drive technical decisions.
• Drive design quality, reliability, and compliance to standards and regulations.
• Assist on-time completion of Design Control Deliverables.
• Maintain risk management files for commercial products via periodic review of risk documents, complaints and nonconformance trends.
• Maintain release testing plans and associated test methods and procedures.
• Lead CAPA/NCR/SCAR investigations and reports.
• Review supplier documentation in accordance with established requirements.
• Support internal & external audits, complaint investigations, quality system development (as required), and manufacturing process development & qualification for product changes.
• Support DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.

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
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree