Senior Manufacturing Systems Engineer – DeltaV

About the role

Amgen is hiring a Senior Manufacturing Systems Engineer (DeltaV) for its Facilities & Engineering group at its new drug substance manufacturing plant, the FleX batch facility. The role leads technical projects, drives innovation and supports upstream, downstream and solution preparation automation, partnering with the capital project team to design, build, commission and qualify new equipment and systems.

Key responsibilities

• Support capital projects with a focus on safety and on-time facility start-up, working with process engineering to develop process control automation solutions mainly using Emerson DeltaV DCS.
• Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
• Develop and maintain specifications, SOPs and operating standards, and mentor site technical automation capabilities.
• Act as system owner for Upstream, Downstream and/or Solution Prep automation, providing 24x7 onsite/on-call support, troubleshooting and spare parts management.
• Lead root cause analysis, incident investigations and troubleshooting of process control issues.
• Support new product and new technology introductions through automation engineering assessments, configuration changes and qualification runs.
• Prepare and review SOPs and cGMP documents, and lead projects to improve process equipment, utilities and facilities.

Required profile

• High school diploma / GED and 10 years of engineering experience, or Associate's degree and 8 years, or Bachelor's degree and 4 years, or Master's degree and 2 years, or Doctorate.
• Preferred: degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering.
• Self-directed team player ready to mentor engineers, with strong leadership, technical writing and communication skills.
• On-site role with up to 10% domestic or international travel.

Required skills

• Emerson DeltaV and process control network design, including network segregation.
• Virtual infrastructure design and OPC, Foundation Fieldbus and Profibus integration.
• Knowledge of 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP and GMP.
• Experience with upstream/downstream/solution prep unit operations such as media, harvest, mixers, bioreactors, chromatography and viral filtration.
• Capital project lifecycle management, from design to validation.

What we offer

• Base salary of $136,906.95 to $185,227.05, plus a comprehensive total rewards package.
• Competitive benefits and a collaborative, science-based culture.