Clean Utilities Sr Engineer

Responsibilities Design, build, commission, and qualify new equipment and systems needed for drug substance production. Develop subject‑matter expertise to support operations at startup. Provide system ownership for Clean Utility and Plant Utility systems and equipment. Support engineering for design, construction, start‑up, commissioning, and qualification of new or modified systems. Identify and lead engineering‑based improvements or upgrades in small to medium scope and complexity. Develop business cases to support project completion when required. Develop equipment maintenance programs, ensure spare part availability, and coordinate maintenance execution. Ensure systems are installed, operating safely, and comply with environmental health and safety practices. Ensure commissioning and qualification are completed in alignment with GMP requirements and interact with regulatory inspectors as necessary. Apply basic engineering principles in daily operation, maintenance, and troubleshooting of plant systems. Monitor systems to identify performance risks and implement risk‑reducing strategies. Provide troubleshooting support to reduce production downtime, including root cause analysis and corrective/preventive actions. Support new product/technology introductions by engineering assessments, equipment modifications, and engineering runs. Advance the use of condition‑based and predictive maintenance practices by incorporating advanced data analytics. Own investigations of abnormal conditions through deviation and business processes. Qualifications Basic Qualifications High school diploma / GED and 10 years of Engineering/Maintenance experience Associate’s degree and 8 years of Engineering/Maintenance experience Bachelor’s degree and 4 years of Engineering/Maintenance experience Master’s degree and 2 years of Engineering/Maintenance experience Doctorate degree Preferred Qualifications Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering. 4+ years of relevant work experience with 2+ years in a Biopharmaceutical manufacturing environment. Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, Clean Air generation, and distribution; and other Plant Utility equipment (Chilled Water, chillers, cooling towers, steam boilers, air compressors, etc.). Experience with equipment and facility control system operation, logic, and troubleshooting. Ability to analyze problems and develop engineering solutions using data‑driven techniques (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/processes such as change control, non‑conformances, corrective and preventive actions, and qualifications/validation. Experience applying engineering principles to system modifications, new process introductions, and capital projects. Understanding of capital project execution in a GMP Biopharmaceutical Production facility (procurement, construction, start‑up, validation). Understanding of safety requirements in a GMP Biopharmaceutical Production facility. Independent, organized, able to multi‑task in project environments, and skilled in communication, facilitation, and teamwork. Strong leadership, technical writing, and presentation skills. Flexibility for 24/7 operations, including occasional after‑hours coverage. Domestic and international travel ability. Benefits & Compensation Salary Range: $115,494.60 – $156,257.40 per year (U.S. – excluding Puerto Rico). Amgen offers a Total Rewards Plan that includes health, welfare, retirement and savings plans, life and disability insurance, flexible spending accounts, discretionary annual bonus, long‑term equity incentives, and generous time‑off plans. 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, veteran status, disability status, or other protected characteristics. Reasonable accommodations are provided for individuals with disabilities. #J-18808-Ljbffr Amgen Inc. (IR)