Senior Process Engineer

Company: Amgen
Location: Holly Springs
Posted on: January 4, 2026

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 Lets do this. Lets change the world. 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. 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 coordinating maintenance activities to ensure systems are in proper working order. Ensure systems are installed and operating safety 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. System guidance to identify performance risks and implement risk reduction strategies. Providing 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 Associates degree and 8 years of Engineering experience OR Bachelors degree and 4 years of Engineering experience OR Masters degree and 2 years of Engineering experience OR Doctorate degree Preferred Qualifications: Bachelors 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, well 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.

Keywords: Amgen, Danville , Senior Process Engineer, Engineering , Holly Springs, Virginia