Senior Manager Manufacturing Systems Engineering

About the role

Join Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in single-use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, supporting Amgen's plan to be a carbon-neutral company by 2027.

In this role, you will oversee the Automation Engineering team, lead technical projects, and drive innovation to support manufacturing automation needs. You will solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives while providing leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

This position reports to the Facilities & Engineering (F&E) Director and will partner closely with the corporate engineering team during design, build, commissioning, and qualification phases. You will develop automation domain expertise and support operational readiness, focusing on manufacturing automation, as well as hiring and training staff required for startup and operations.

Responsibilities

• Build and lead a team of Automation Engineering professionals and serve as the main point of contact for the Automation engineering function.
• Support design reviews while partnering closely with the corporate engineering team.
• Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements.
• Ensure operational capability aligns with manufacturing requirements, GMP regulations, and on-time project delivery.
• Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS).
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Partner with various organizational units to support operational readiness, document reviews, deviation investigation, and change controls.
• Provide mentoring to develop and accelerate site technical automation capabilities.
• Accountable for Automation System Administration, Automation System Operating Systems (OS) and HotFix assessments and rollout, preventative and corrective maintenance, Automation System spare parts management, and ownership of departmental Standard Operating Procedures (SOPs).
• Manage day-to-day automation support including 24x7 onsite/on-call support, troubleshooting, and daily manufacturing and engineering meetings.
• Establish clear expectations and priorities for staff, encouraging a culture of continuous improvement, partnership, and knowledge sharing.
• Provide development opportunities, feedback, and actively listen to staff.
• Collaborate effectively with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners).
• Perform automation change assessments, implement automation system configuration changes, and support engineering and process qualification runs.
• Represent automation in cross-functional design reviews and audits.
• Identify new and innovative ways to improve business processes, efficiency, and cost-effectiveness.
• Lead continuous improvement initiatives focused on safety, reliability, efficiency, and sustainability.
• Maintain data integrity in accordance with current Amgen and industry standards.
• Provide technical support to troubleshoot, identify, and resolve process and system issues as needed.
• Provide strategic, tactical management, and leadership to ensure 24x7 reliability of plant operations.
• Participate in the budgeting process for Automation engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.
• Up to 10% domestic/international travel.

Requirements

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience.
• Minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering.
• Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.
• Hands-on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments.
• Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing.
• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
• In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
• Experience working in a regulated environment (e.g., cGMP, OSHA, EPA), interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• Direct knowledge of biopharmaceutical production facilities with experience in Upstream (Seed train, production Bioreactors, Harvest) and Downstream Purification (e.g., Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
• Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage.

Benefits

Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards, supporting your professional and personal growth and well-being. The organization fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to advance science and serve patients.