Process Engineer - Solution Prep, Upstream, and Downstream

Process Engineer – Solution Prep, Upstream, and Downstream Responsibilities Design, build, commission, and qualify new equipment and systems needed for drug substance production, partnering closely with the corporate engineering team. Support site design, construction, start‑up, and operational readiness, ensuring commissioning and qualification of manufacturing systems meet GMP requirements and align with regulatory standards. Coordinate system installation, safety compliance, and environmental health & safety practices, and serve as the system owner during regulatory inspections. Assist with new product or technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Provide system support for biopharmaceutical process equipment and identify engineering‑based improvements or upgrades to equipment or facility systems. Develop business cases for improvements, translate design requirements into specifications, and support construction, start‑up, and validation activities. Develop equipment maintenance programs, manage spare parts availability, and coordinate maintenance activities to maintain system reliability. Identify performance risks and implement risk reduction strategies, conduct root‑cause analysis, and execute corrective/preventive actions. Provide rotational on‑call and shift support to guarantee 24/7 reliability of Solution Prep, Upstream, and Downstream systems. Travel up to 10% domestically or internationally as needed. Qualifications Basic Qualifications: Master’s degree OR Bachelor’s degree with 2 years of engineering experience Associate’s degree with 6 years of engineering experience High school diploma/GED with 8 years of engineering experience Preferred Qualifications: Bachelor’s degree in Chemical, Mechanical, or related engineering discipline 3+ years of relevant work experience, including 2+ years in biopharmaceutical operations or manufacturing Direct knowledge of design and troubleshooting of GMP biopharmaceutical production equipment/systems, especially Solution Prep, Upstream, and Downstream purification equipment (e.g., weigh and dispense, vessels, cell culture reactors, centrifuges, chromatography, viral filtration, UFDF skids, autoclaves, CIP, washers, clean steam, WFI) Data‑driven problem‑solving experience (e.g., data analytics, root‑cause analysis, SPC, Six Sigma, predictive maintenance) Experience working in a regulated environment (cGMP, OSHA, EPA) and familiarity with GMP quality systems (change control, non‑conformances, C&PA, qualification/validation) Project management skills: procurement, construction, start‑up, validation, capital project oversight in a GMP facility Knowledge of safety requirements in a GMP biopharmaceutical production environment Strong communication, facilitation, teamwork, leadership, technical writing, and presentation skills Ability to support 24/7 operations, including after‑hour coverage, and willingness to travel domestically/internationally Benefits Salary Range: $88,281 – $119,439 USD. Amgen offers competitive and comprehensive total rewards plans, a collaborative culture, and opportunities for professional growth and well‑being. 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 provide reasonable accommodation for individuals with disabilities in the application or interview process, to perform essential job functions, and for other employment benefits. Please contact us to request accommodation. #J-18808-Ljbffr Amgen Inc. (IR)