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Senior Engineer 2, Process Development
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 a Senior Engineer 2, Process Development, 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
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, you’ll have the opportunity to:
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Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product design
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Identify and recommend best-in-class manufacturing equipment and process technologies used within the medical device/pharmaceutical industry
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Design and develop manufacturing processes, equipment, and tooling that are lean and mistake-proof
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Develop equipment requirements specifications and work with suppliers to quote, procure, and implement into manufacturing
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Develop process validation plans, lead the execution of plans, and document results in reports
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Lead cross-functional teams to develop pFMEA’s and other risk assessments and implement effective manufacturing controls, managing project plans and schedules
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Collaborate with Operations team to develop effective process work instructions
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Implement equipment calibration and maintenance plans/schedules
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Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions
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Develop and validate test methods used in manufacturing
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Lead CAPA projects and problem-solving efforts
To succeed in this role, you’ll need:
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Bachelor’s 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)
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Experience in medical device, pharmaceutical, GMP, or regulated industry preferred
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Experience with process validation (IQ/OQ/PQ) preferred
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Experience with design and troubleshooting automated equipment preferred
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Six Sigma Black Belt preferred
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Proficient in the use of Minitab, MS Project, and SolidWorks preferred
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Experience with Lean principles and metrics, problem solving methodologies, DMAIC, SPC, process capability analysis
In return, we offer you:
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Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
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Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
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A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.
The most likely base pay range for this position is $120k - $168k 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.
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.
Accessibility and Reasonable Accommodations:
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 [email protected].
To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.
Top Skills
What We Do
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the company's partners make progress developing and commercializing their products being developed with ENHANZE®.
We are a diverse team, who are committed to bringing therapies and results to patients. It's not enough to be qualified and experienced at what you do, we are looking for people who believe in our mission and match our values.
We are building a company where people can pursue their career goals in a supportive and collaborative team environment. Visit www.halozyme.com/careers for more details.
We are Halozyme.
