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Senior Manager Manufacturing Systems Engineering

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Amgen

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Location:
United States , Holly Springs

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

148715.15 - 201202.85 USD / Year
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Job Description:

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Job Responsibility:

  • Oversee the Automation Engineering team, lead technical projects, and drive innovation and support manufacturing’s automation needs
  • Solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives
  • Provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations
  • 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
  • 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 tasks including operational readiness, document reviews, deviation investigation and change controls
  • Provide mentoring to develop and accelerate site technical automation capabilities
  • Lead a team of Automation engineer professionals and serve as the main point of contact for Automation engineering function
  • 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 24 x 7 onsite/on-call support, troubleshooting, and daily manufacturing and engineering meetings
  • Establish clear expectations and priorities to staff
  • Effectively collaborate 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
  • Lead continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability
  • Perform and maintain data integrity in accordance with the 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 day-to-day 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 experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
  • 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, etc.), experience 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 facility with direct experience with 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 as required to support 24/7 operations, requiring occasional after-hours engineering coverage
What we offer:

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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