Principal Manufacturing Systems Engineer – Upstream / Downstream Process Automation

Amgen SA; Holly Springs (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

Amgen is seeking a Principal Manufacturing Systems Engineer for upstream/downstream process automation at the FleXBatch site. You will act as a subject matter expert, driving innovation and implementing scalable automation across manufacturing while partnering with engineering, quality, and manufacturing teams to ensure compliance and 24/7 operations.

The role requires deep knowledge of DeltaV, GMP, and cross-functional leadership, with 24x7 operations support and potential travel up to 10%.

Qualifications

• PhD/masters with engineering experience as stated.
• Knowledge of GMP/Regulatory requirements and 21 CFR Part 11.
• Experience with automation design for Upstream/Downstream bioprocessing.
• Mentorship and cross-functional leadership experience.
• Travel up to 10% domestically or internationally.

Responsibilities

• Site design, construction, start-up, and operational readiness tasks.
• Lead commissioning and qualification of process equipment automation.
• Collaborate with engineering to develop DeltaV automation solutions.
• Provide 24x7 automation support and on-call coverage.
• Mentor junior engineers and drive continuous improvement.

Skills

Automation engineering

Cross-functional collaboration

Leadership

Process automation

Regulatory compliance

Education

PhD in Engineering

Masters in Engineering

Bachelors in Engineering

Tools

Emerson DeltaV

OPC

Foundation Fieldbus

Job description

HOW MIGHT YOU DEFY IMAGINATION?

You’veworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experience,and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over10 million patientsworldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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.

Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation

What you will do

Let’s do this! Let’s change the world! In this vital role, you will serve as a subject matter expert in automation engineering, driving innovation, solving complex challenges, and influencing the design and implementation of automation systems for upstream and downstream bioprocessing. You will collaborate across engineering, manufacturing, and quality teams to ensure robust, compliant, and scalable automation solutions that support 24/7 operations.

The Principal Manufacturing Systems Engineer will join the Facilities & Engineering (F&E) group. This role will partner closely with the corporate engineering team during the design, build, commissioning, and qualification phases and later transitioning to supporting daily operations for drug substance production. This role will be instrumental in developing automation domain expertise and supporting operational readiness.

Job responsibilities include:

• Site design, construction, start-up, and operational readiness:
  • Support design reviews while partnering closely with the corporate engineering team to represent site interests and requirements.
  • Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation 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).
  • Lead commissioning and qualification efforts, including Automation Installation Verification/Automation Check Out (IV/ACO), ensuring compliance with GMP and project timelines.
  • 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.
• Site Operations:
  • Act as responsible system owner for automation systems, providing day-to-day automation support including 24 x 7 onsite/on-call support, troubleshooting, and daily automation team meetings.
  • Provide technical leadership to troubleshoot, identify and resolve process and system issues as needed.
  • 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.
  • Lead continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability, such as cycletimes, yields, and efficiency of unit operations in manufacturing.
  • Perform and maintain data integrity in accordance with the current Amgen and industry standards.
  • Serve as a technical mentor to junior engineers and cross-functional teams.
  • Influence automation strategy and standardization across the site and network.
  • Represent plant automation in Amgen global network forums related to automation and process control.
  • Represent automation during audits, and regulatory inspections.
  • Stay current with emerging technologies and industry trends to identify opportunities for innovation.
  • Provide strategic, tactical management, and leadership to ensure 24x7 day-to-day reliability of plant operations.
  • Up to 10% domestic/international travel

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of engineering experience
• Master’s degree and 4 years of engineering experience
• Bachelor’s degree and 6 years of engineering experience
• Associate’s degree and 10 years of engineering experience
• High school diploma / GED and 12 years of engineering experience

Preferred 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, 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.
• Deep understanding of biopharmaceutical manufacturing processes including 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.
• Proven ability to influence cross-functional teams and drive technical decisions.
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage