Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.

In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.

We look forward to discovering your talents.

Validation Engineer-Contract-This position will be based in our Minnetonka, MN site.

Welcome to an inspired career!

At Halozyme, we are reinventing the patient’s 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 a Validation Engineer-Contract 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 a Validation Engineer for our Minnetonka, MN manufacturing site, you will lead validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations. This position is the owner of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.

In this role, you’ll have the opportunity to:

• Develop validation plans, protocols and reports for assembly and packaging processes.
• Develop and manage validation standard operating procedures in compliance with regulatory requirements.
• Develop and maintain validation protocol and report templates.
• Develop test method validation (TMV) protocols and reports for automated and manual inspection methods.
• Provide quality engineering support for semi-manual and automated equipment development.
• Review equipment URS, FAT/SAT against quality requirements
• Support design transfer of internal manufacturing processes
• Perform statistical analysis of validation and production data.
• Supports manufacturing process development & qualification for product changes.

To succeed in this role, you’ll need:

• Bachelor level degree in Engineering (Mechanical or Biomedical) or related Science with minimum of 5 years relevant experience in the medical device industry
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
• Good statistical data analysis skills (Minitab)
• Design for Six Sigma and Critical to Quality training and experience a plus
• Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus.
• Ability to educate stakeholders, customers and management.
• Experienced working with cross-functional teams
• Experienced with participation in audits.
• ASQ certification a plus

In return, we offer you:

• Hybrid work flexibility-requires 3 days weekly to work on site and more as needed.
• 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 $50 per hour to $75 per hour. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation.