Process Development Engineer

Career Category Process Development Job Description Join Amgen's Mission to Serve Patients At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact. Process Development Engineer What you will do • Applies expertise in the successful coordination of multiple, complex, non-routine activities including tech transfer process qualification, process performance monitoring, floor support, troubleshooting of unit operations. • Support/lead complicated investigations, providing concise communications to teams and leadership • Compile and analyze process data using tools such as excel, JMP, SIMCA to inform future decision-making and take predictive action • Author technical protocols, technical assessments, and product impact assessments • Verify data in technical reports, spreadsheets, and regulatory filings • Utilize strong written and verbal communication skills in technical writing and presentations All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities. What we expect of you • Master’s degree OR • Bachelor’s degree and 2 years of directly related experience OR • Associate’s degree and/or 4 years of directly related experience OR • High school diploma / GED and 6 years of directly related experience • 4+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries • At least 2 years’ experience with regulated environments (i.e. cGMP) required • In depth cell culture process knowledge, including single-use technologies and harvest technologies • Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production • Possess basic understanding of regulatory and cGMP requirements • Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements • Able to escalate relevant issues to project lead and line management • Independently motivated but also work well in team environment • Strong communication skills (technical writing and verbal communication/presentation) • Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company. What you can expect of us As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally. Apply now and help transform the lives of patients while transforming your career. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .