Senior Engineer 2, Process Development

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.Welcome to an inspired career.At Halozyme, we're proud of what we do, and we continue to do more. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission.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 impactThe 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:Collaborate with cross-functional teams to understand user/product requirements and recommend design for manufacturability elements for the product designIdentify and recommend best-in-class manufacturing equipment and process technologies used within the medical device/pharmaceutical industryDesign and develop manufacturing processes, equipment, and tooling that are lean and mistake-proofDevelop equipment requirements specifications and work with suppliers to quote, procure, and implement into manufacturingDevelop process validation plans, lead the execution of plans, and document results in reportsLead cross-functional teams to develop pFMEA's and other risk assessments and implement effective manufacturing controls, managing project plans and schedulesCollaborate with Operations team to develop effective process work instructionsImplement equipment calibration and maintenance plans/schedulesDesign experiments and gather/assess/summarize data using statistical tools to make conclusions and decisionsDevelop and validate test methods used in manufacturingLead CAPA projects and problem-solving effortsTo succeed in this role, you'll need: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)Experience in medical device, pharmaceutical, GMP, or regulated industry preferredExperience with process validation (IQ/OQ/PQ) preferredExperience with design and troubleshooting automated equipment preferredSix Sigma Black Belt preferredProficient in the use of Minitab, MS Project, and SolidWorks preferredExperience with Lean principles and metrics, problem solving methodologies, DMAIC, SPC, process capability analysisIn 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.The most likely base pay range for this position is $116k - $162k 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 hrbox@halozyme.com.