Engineer

Job description

Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Engineer What you will do Let’s do this! Let’s change the world! Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients’ lives? Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Advancing science and helping patients – these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people’s lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities, from training and education to expanding current job responsibilities. As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network. The technology transfer responsibilities for this role requires a mostly on-site presence. We provide process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing processes in a cGMP environment. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen’s Thousand Oaks site. Specific Responsibilities include but are not limited to: Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision will evaluate, select, and apply standard engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. Transfer processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance. Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications. Continuous improvement mindset; seeks out opportunities to gain efficiencies within business process workstreams Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. Work with consultants, architects, and engineering firms on development of standard design documents. Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments Support non-standard shift organization and extended hours, as per business needs. Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations Provide routine process monitoring and troubleshooting Provide technical support for process related deviations (NCs), CAPAs and change controls Represent process development and interface with other functions such as Manufacturing, Quality, Validation and Regulatory What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative team player with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of Engineering or Operations experience OR Associate’s degree and 6 years of Engineering or Operations experience OR High school diploma / GED and 8 years of Engineering or Operations experience Preferred Qualifications: Education background in Chemical Engineering, Bioengineering or Biotechnology 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes. Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale Experience working with commercial manufacture of biologics using single use technology Basic understanding cGMP requirements of manufacturing at large scale. Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules Experience in the analysis of data generated from a variety of analytical techniques Regulatory knowledge and interactions Project management skills Strong oral and verbal communication and presentation skills Person will have strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills Ability to develop and follow detailed protocols Independently motivated with ability to multi-task and work in teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annu