Senior Process Engineer

Join to apply for the Senior Process Engineer role at BioSpace . Be among the first 25 applicants. At Amgen, if you feel like you are 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 lie 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. Senior Process Engineer What You Will Do Provide system ownership for biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering‑based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order. Ensure systems are installed and operating safely and stay in sync with pertinent environmental health/safety practice, rules and regulations. Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors. Guide system performance risk identification and implement risk reduction strategies. Provide problem‑solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. 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 High school diploma / GED and 10 years of engineering experience OR Associate’s degree and 8 years of engineering experience OR Bachelor’s degree and 4 years of engineering experience OR Master’s degree and 2 years of engineering experience OR Doctorate degree Preferred Qualifications Bachelor’s degree in Chemical or Mechanical Engineering 6+ years’ of relevant work experience with 5+ years’ experience in biopharmaceutical operations/manufacturing environment with a focus on upstream unit operations Direct knowledge of design and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration 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 (~10%). 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. Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Management and Manufacturing. #J-18808-Ljbffr BioSpace