Process Engineer - Solution Prep, Upstream, and Downstream — US - North Carolina - Holly Springs

Career Category Engineering Job Description Join 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. 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. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Process   Engineer     -   Solution Prep,   Upstream , and   Downstream What you   will do   In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to   support operations upon start - up.   Site design, construction, start-up, and operational readiness:   • Support the commissioning and qualification of   manufacturing   systems in alignment with GMP requirements and interact with regulatory inspectors .   • Ensure   systems   are installed and   operate   safely   and   comply with   pertinent environmental health/safety   practice ,   rules   and regulations .   • Support commissioning and qualification of systems   to ensure their operational capability   is aligned   with   manufacturing requirements and   GMP   regulations.   • I nteract with regulatory inspectors   as a manufacturing systems owner to communicate and   demonstrate   appropriate regulatory   compliance   of   operating systems .   • Assist   with   new product/technology introductions by performing engineering assessments,   implementing equipment modifications, and supporting engineering runs .     Site O perations:   • Provide system   support   for   b iopharmaceutical process equipment.   Assist   in   identifying   and implementing engineering-based improvements or upgrades to equipment or facility systems.     • Support the development   of   business cases for improvements,   identific ation of   design requirements, and translati on of   these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of   improvements .   • Develop equipment maintenance programs, ensure the availability of spare parts, and   coordinate   maintenance activities to ensure systems are in proper working order.   • Provide   s ystem guidance to   identify   performance risks and implement risk reduction strategies.   • Provid e   problem solving support to reduce production downtime. This   includes   supporting technical root cause analysis and implementation of corrective/preventive   action.   • Provide rotational on-call support   and/or shift support   based on business needs   to   ensure   24x7 day-to-day   reliability of   Solution Prep,   Upstream and Downstream systems   for plant operations.   • On-site and up to   10% domestic/international travel .   ​ What we expect   of   you   We are all different, yet we all use our unique contributions to serve patients. The engineering professional we   seek   enjoys challenges and is motivated to help serve patients with these qualifications.   Basic Qualifications:   Master’s degree    OR   Bachelor’s   degree and 2 years of   Engineering   experience   OR    Associate’s   degree and 6 years of   Engineering   experience   OR     High school diploma / GED and 8 years of   Engineering   experience   Preferred Qualifications:   • Bachelor ’   s degree in Chemical or Mechanical Engineering   or similar   engineer   discipline.   • 3 +   years'   of relevant work experience with   2 + years' experience in Biopharmaceutical   operations/manufacturing environment   • Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and  Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.   • Ability to analyze problems, develop and propose engineering solutions in a scientific   manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause   Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)   • Experience working in a regulated environment ( e.g.   cGMP, OSHA, EPA, etc.) and   familiarity with GMP quality systems/processes such as change control, non-conformances,   corrective and preventative actions, and qualifications/validation   • Experience applying engineering principles to the design and implementation of system   modifications, introduction of new processes, and the oversight of capital projects   • Understanding of capital projects in a GMP Biopharmaceutical Production facility including   procurement, construction, startup, and validation   • Understanding of   safety requirements working in a GMP Biopharmaceutical Production   facility.   • Independent, ambitious, organized, able to multi-task in project environments, and skilled in   communication, facilitation, and teamwork   • Collaborative   teammate   prepared to work in and embrace a   team based   environment that   relies on communication for effective decision-making   • Strong leadership, technical writing, and communication/presentation skills   • Work schedule flexibility as   required   to support 24/7 operations, requiring occasional   after   hours   engineering coverage   • Ability for domestic/international travel .     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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team! 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 to 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. . Salary Range 88,281.00USD -119,439.00 USD