Senior Manufacturing Systems Engineer - Holly Springs, NC

Senior Manufacturing Systems Engineer:
Automation What You Will Do

• Provide automation technical leadership to a team of engineers building and maintaining automation systems for GMP Drug Substance Plant Operations.
• Collaborate with the capital project team to deliver robust process automation systems for the new plant.
• Work with stakeholders and end‑users to capture and synthesize process requirements, and develop solutions using Amgen’s standard automation platform.
• Support design phases to ensure alignment with Amgen specifications, incorporation of the latest technology, and compliance with safety requirements.
• Verify vendor Foundations Acceptance Tests (FAT) to confirm control strategy and software code meet Amgen requirements.
• Create and maintain engineering and maintenance documentation and associated procedures for delivered solutions.
• Collaborate with cross‑functional teams to develop a commissioning and qualification plan or strategy.
• Support commissioning and qualification, including Automation Installation Verification/Automation Check‑Out (IV/ACO).
• Assist QA partners in performing computerized system validation in a GxP environment.
• Conduct Data Integrity Assessments (DIA) in accordance with Amgen and industry standards.
• Own and drive completion of change controls, CAPAs, and deviations.
• Lead and support technical root‑cause analysis, incident investigations, and troubleshooting.
• Lead functional area projects to improve process equipment, utilities, facilities, and large capital projects integrating new drug‑substance manufacturing technologies.
• Drive continuous improvement of automation systems to enhance operational workflows, safety, reliability, efficiency, and sustainability.
• Support day‑to‑day operations, including on‑call rotation support.

• 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 Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field.
• Direct knowledge of automation system design.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience automating GMP biopharmaceutical equipment and systems such as buffer prep & hold, chromatography, single‑use mixing vessels, depth filtration, and solution prep.
• Experience integrating various OEM automation software.
• Experience with Emerson Delta
  
  V DCS system and advanced troubleshooting, system integration using OPC, Foundation Fieldbus, and Profibus technologies.
• Ability to interpret and apply GAMPs and GMPs, familiarity with documentation in highly regulated environments (e.g., 21 CFR Part 11, ASTM 2500, S88, and S95).
• Self‑directed team player who works cross‑functionally.
• Strong leadership, technical writing, and communication skills.
• Ability to travel domestically and internationally.

Amgen is a global biopharmaceutical company dedicated to serving patients living with serious illnesses. The company’s culture is collaborative, science‑based, and innovative. The new FleX Batch facility combines disposable technologies with traditional stainless‑steel equipment, focuses on industry 4.0 capabilities, and embeds sustainability innovations to reduce carbon and waste.

Base salary range: $147,421 – $177,467 USD. Total rewards include retirement and savings plans with generous company contributions; group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; discretionary annual bonus program; stock‑based long‑term incentives; award‑winning time‑off plans; bi‑annual company shutdowns; and flexible work models where possible.

Holly Springs, North Carolina.

This role is open to Veterans, transitioning military, National Guard and Reserve members, military spouses, wounded warriors, and their caregivers.