Senior Manufacturing Systems Engineer – DeltaV Batch
Amgen
June 30, 2026
On-site
Holly Springs, NC
Operations
Senior Manufacturing Systems Engineer – DeltaV Batch
Responsibilities:
- Lead technical projects and support manufacturing upstream, downstream, and solution preparation automation.
- Partner with capital project teams to design, build, commission, and qualify new drug substance equipment and systems.
- Support site design/construction/start-up with focus on safety and on-time readiness.
- Collaborate with process engineering to develop automation control solutions using Emerson DeltaV DCS.
- Support commissioning/qualification including Automation Installation Verification/Automation Check Out (IV/ACO).
- Support operational readiness, document reviews, deviation investigation, and change controls.
- Develop/maintain specifications, SOPs, and operating standards across organizational units.
- Mentor engineering staff to build site automation capabilities.
- Act as system owner for Upstream, Downstream, and/or Solution prep automation processes.
- Provide 24x7 onsite/on-call operational support, troubleshooting, process and utility automation, and spare parts management.
- Lead/support functional and capital projects integrating new manufacturing technologies.
- Lead/support technical root cause analysis, incident investigations, and troubleshooting for process control issues.
- Support NPI/new technology introductions (automation assessments, configuration changes, qualification runs).
- Prepare/review SOPs and cGMP documents.
- On-site role with up to 10% domestic/international travel.
Basic Qualifications:
- High School Diploma/GED + 10 years Engineering OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications:
- Degree in Electrical Engineering/Computer Science, Chemical Engineering, or Biotech Engineering.
- Extensive Emerson DeltaV experience; process control network design; virtual infrastructure; OPC, Foundation Fieldbus, Profibus integration.
- Experience integrating OEM automation software and field instrumentation.
- Process control engineering/troubleshooting in GMP biopharmaceutical automation.
- Upstream/downstream/solution prep experience (e.g., media, harvest, mixers, bioreactors, chromatography, viral filtration, UF/DF).
- Programming, design, installation, and lifecycle management of manufacturing controls/automation/instrumentation.
- Knowledge of 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
- Capital project lifecycle management (conceptual to validation).
- Self-directed team player; strong leadership, technical writing, and communication/presentation skills.
Benefits:
- Competitive and comprehensive Total Rewards Plans (in addition to base salary).
Application:
- Apply now at careers.amgen.com.
Responsibilities:
- Lead technical projects and support manufacturing upstream, downstream, and solution preparation automation.
- Partner with capital project teams to design, build, commission, and qualify new drug substance equipment and systems.
- Support site design/construction/start-up with focus on safety and on-time readiness.
- Collaborate with process engineering to develop automation control solutions using Emerson DeltaV DCS.
- Support commissioning/qualification including Automation Installation Verification/Automation Check Out (IV/ACO).
- Support operational readiness, document reviews, deviation investigation, and change controls.
- Develop/maintain specifications, SOPs, and operating standards across organizational units.
- Mentor engineering staff to build site automation capabilities.
- Act as system owner for Upstream, Downstream, and/or Solution prep automation processes.
- Provide 24x7 onsite/on-call operational support, troubleshooting, process and utility automation, and spare parts management.
- Lead/support functional and capital projects integrating new manufacturing technologies.
- Lead/support technical root cause analysis, incident investigations, and troubleshooting for process control issues.
- Support NPI/new technology introductions (automation assessments, configuration changes, qualification runs).
- Prepare/review SOPs and cGMP documents.
- On-site role with up to 10% domestic/international travel.
Basic Qualifications:
- High School Diploma/GED + 10 years Engineering OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications:
- Degree in Electrical Engineering/Computer Science, Chemical Engineering, or Biotech Engineering.
- Extensive Emerson DeltaV experience; process control network design; virtual infrastructure; OPC, Foundation Fieldbus, Profibus integration.
- Experience integrating OEM automation software and field instrumentation.
- Process control engineering/troubleshooting in GMP biopharmaceutical automation.
- Upstream/downstream/solution prep experience (e.g., media, harvest, mixers, bioreactors, chromatography, viral filtration, UF/DF).
- Programming, design, installation, and lifecycle management of manufacturing controls/automation/instrumentation.
- Knowledge of 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
- Capital project lifecycle management (conceptual to validation).
- Self-directed team player; strong leadership, technical writing, and communication/presentation skills.
Benefits:
- Competitive and comprehensive Total Rewards Plans (in addition to base salary).
Application:
- Apply now at careers.amgen.com.