Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream

Amgen Senior Manager Manufacturing System Engineering – Bulk Drug Substance – Upstream Amgen’s next‑generation manufacturing facility will blend cutting‑edge single‑use technologies with traditional stainless‑steel equipment. We are seeking a Senior Manager Manufacturing System Engineering to lead the Automation Engineering team, drive technical projects, and support 24/7 manufacturing operations. Responsibilities Oversee and lead the Automation Engineering team, serving as the primary point of contact for Automation engineering functions. Drive technical projects and support automation needs across the site design, construction, start‑up, and operational readiness phases. Partner closely with the corporate engineering team during design, build, commissioning, and qualification of automation systems. Execute and support commissioning and qualification of process equipment automation in alignment with GMP requirements. Collaborate with the site Process Engineering team to develop process‑control automation solutions using Emerson DeltaV DCS. Support panel validation and Automation Installation Verification/Automation Check‑Out (IV/ACO) activities. Coordinate with various units for operational readiness, documentation reviews, deviation investigation, and change controls. Mentor staff to accelerate site technical automation capabilities. Manage day‑to‑day automation support, including 24/7 on‑call coverage, troubleshooting, and manufacturing/engineering meetings. Lead automation system administration, OS maintenance, hot‑fix assessments, spare‑parts management, and SOP ownership. Perform automation change assessments, system configuration changes, and support engineering and process qualification runs. Represent automation in cross‑functional design reviews, audits, and continuous‑improvement initiatives. Maintain data integrity in accordance with Amgen and industry standards. Provide strategic, tactical management, and leadership to ensure 24/7 plant reliability. Participate in the budgeting process for automation engineering, forecasting costs, managing expenditures, and allocating resources. Travel domestically or internationally up to 10%. Required Qualifications Education/Experience Combinations: High school diploma / GED and 12 years of engineering experience Associate’s degree and 10 years of engineering experience Bachelor’s degree and 8 years of engineering experience Master’s degree and 6 years of engineering experience Doctorate degree and 2 years of engineering experience Minimum of 2 years of direct people‑management or leadership experience (teams, projects, or allocation of resources). Preferred Qualifications Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering. Extensive experience with Emerson DeltaV, process‑control network design, and virtual infrastructure implementation. Hands‑on experience with IO‑Link technology for smart sensor/actuator integration. Familiarity with Process Analytical Technology (PAT) tools and real‑time process monitoring. Direct knowledge of integrating OEM automation software and field instrumentation technologies. In‑depth knowledge of industry standards such as 21CFRPart11, ASTM2500, S88, S95, GAMP, GDP, and GMP. Experience in a regulated environment (cGMP, OSHA, EPA, etc.) and interaction with regulatory agencies and inspectors. Experience with Tech Transfer, Process Design, and Commissioning & Qualification. Direct experience with Upstream (seed train, bioreactor, harvest) and Downstream purification processes. Ability to mentor and develop engineering staff and embrace a team‑based culture. Strong leadership, technical writing, and communication/presentation skills. Flexibility to support 24/7 operations and occasional after‑hours coverage. Compensation Salary Range: 148,715.15USD – 201,202.85USD. #J-18808-Ljbffr Amgen Inc. (IR)