Sr. Engineer, ARI Engineering Projects

• Provide technical expertise in the design and integration of upstream and downstream process equipment
• Lead troubleshooting and technical investigations related to process equipment, automation interactions, and operational performance
• Support design, construction, startup, commissioning, and qualification of new manufacturing equipment and facility modifications
• Review and approve engineering deliverables
• Partner with Capital Project teams and Engineering Technical Authorities (ETA) to ensure alignment with Amgen standards and manufacturing requirements
• Support utility tie-ins, operational readiness activities, New Product Introductions and hyper care support following startup
• Lead and support commissioning and qualification activities for GMP process systems
• Identify and implement engineering-based improvements to optimize equipment reliability, throughput, process robustness, and operational efficiency
• Lead root cause analysis and implementation of corrective and preventive actions (CAPAs)
• Support predictive maintenance, reliability initiatives, and process performance monitoring
• Drive a culture of safety, accountability, collaboration, and continuous improvement
• Mentor junior engineers and support development of engineering best practices across the organization

• 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
• Degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or related discipline
• Experience supporting GMP biopharmaceutical manufacturing operations
• Direct knowledge of upstream and/or downstream process equipment including: Bioreactors, Centrifuges, Chromatography systems, UFDF skids, Single-use systems, CIP/SIP systems
• Experience with: Commissioning & Qualification (C&Q), Capital project execution, Lifecycle Management Projects, Process troubleshooting, Operational readiness, Manufacturing support
• Knowledge of GMP quality systems including: Change controls, Deviations, CAPAs, Risk assessments, Validation documentation
• Experience working with DeltaV and process automation systems preferred
• Strong technical problem-solving and communication skills
• Ability to lead cross-functional initiatives in a fast-paced manufacturing environment
• Experience balancing operational support with project execution and continuous improvement initiatives

Experience working with DeltaV and process automation systems preferred

• Health and welfare plans for staff and eligible dependents
• Financial plans with opportunities to save towards retirement or other goals
• Work/life balance
• Career development opportunities
• Competitive employee benefits package including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible