Senior Process Engineer - Solution Prep, Upstream, and Downstream Employer Amgen Location Holly Springs, North Carolina Start date Aug 26, 2026 View more categories View less categories Discipline Engineering , Manufacturing & Production , Process Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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. SeniorProcessEngineer-Solution Prep,Upstream,andDownstream What youwill 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.

This role will develop domainexpertiseand system ownershipto supportprocessoperations, focusing onSolution Prep,Upstream,andDownstreamProcess engineering and plant equipment. Site design, construction, start-up, and operational readiness: Support thedesign andbuildof manufacturingequipmentsystems byaligningdesign reviewprocessesand documentswith site requirements, including equipment design and sizing, architecture and electricaldistribution, and piping and instrumentation diagrams. Supportfactoryacceptancetestingworking in partnershipwith global engineeringduringsiteinstallation,including reviewing protocolsandresolving punch list items. Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practice,rulesand regulationsas well as Amgen global engineering requirements.

Ensurethat systems are installed per the designrequirements. Executeand guidethe commissioning and validationof systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.

Supportexecution of engineering and performance qualification runswhile providinghypercaresupport as needed. Perform engineering assessmentsfor plant equipment operations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired.

Site Operations:

Responsible system ownerforSolution Prep,Upstream,andDownstreamDrug substanceprocess equipment, areas, and systems providingend-to-endsupport for operations. Effectively collaborate with key customers and support groups(e.g.

Manufacturing, Quality, Process Development, Maintenance, network partners)to ensure reliable plant operations. Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipmentas applicable. Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.

This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements intoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment. Developmastermaintenance programsfor equipment, ensure the availability of spare parts, andcoordinate maintenance activities to ensure systems are in proper working order. Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for theprocessequipment. Providetechnical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. Thisincludes leadingtechnical root cause analysis and implementation of corrective/preventiveactions for families of systems. Leadnew product/technology introductions by performing engineering assessments,equipment performance risk assessments,identifyinggaps and owning their remediation,implementing equipment modifications, and supporting engineering runs. Provide rotational on-call support and/or shift support based on business needs to ensure24x7 day-to-dayreliability of Solution Prep, Upstream and Downstream systemsfor plant operations. On-site and up to10% domestic/international travel. What we expectofyou We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

Doctorate degree OR Mastersdegree and 2 years of Engineering experience OR Bachelorsdegree and4years ofEngineeringexperience OR Associatesdegree and8years ofEngineeringexperience OR High school diploma / GED and10years of

Engineeringexperience Preferred Qualifications:

Degree in Chemical or Mechanical Engineeringor similar engineering discipline. 6+years'of relevant work experience with 5+ years' experience in Biopharmaceuticaloperations/manufacturing environment Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Productionfacility equipment/systemswith direct experience withSolution Prep,Upstream,andDownstreampurification equipment suchasweigh and dispense equipment, solution preparation vessels,cell culture reactors, centrifugation, chromatography,viralfiltration skids,andUFDFskidsas well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Experience with Tech Transfer, Process Design, and Commissioning & Qualification. Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation Understanding ofsafety requirements working in a GMP Biopharmaceuticalproductionfacility. Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork. Strong leadership, technical writing, and communication/presentation skills Work schedule flexibility asrequiredto support 24/7 operations. 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, 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. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Associate Director, Drug Product Manufacturing Waltham, MA Senior Drug Product MSAT Engineer Rensselaer, New York Process Development Senior Scientist Thousand Oaks, California