Senior Manufacturing Systems Engineer: Automation PLC
Amgen
August 26, 2026
On-site
Holly Springs, NC
Operations
Senior Manufacturing Systems Engineer: Automation PLC
Responsibilities:
- Provide automation technical leadership for GMP Drug Substance Plant Operations.
- Develop and maintain automation solutions using PLCs (Allen Bradley, Siemens, etc.) and Emerson DeltaV integration.
- Develop and maintain SCADA, Trailblazer reporting, equipment PLCs, and interface hardware.
- Lead/support standalone system implementation and start-up; guide control panel/HMI layout and design (power distribution, grounding, I/O assignments).
- Partner with process SMEs to translate process requirements into digital automated solutions.
- Lead continuous improvement/innovation for standalone system efficiency and sustainability.
- Synthesize requirements to deliver automation solutions that improve workflow and productivity.
- Document delivered solutions; support computerized systems validation in a GxP environment and maintain Data Integrity Assessments.
- Build business processes aligned to project scope/timelines; develop engineering policies/procedures across organizations.
- Ongoing ops: lead functional/capital projects integrating new drug substance manufacturing technologies; perform root cause analysis, incident investigations, troubleshooting; support NPI/technology introductions; provide 24x7 onsite/on-call support, maintenance, and spare parts management.
Basic Qualifications:
- High School Diploma/GED + 10 yrs engineering OR Associate’s + 8 yrs OR Bachelor’s + 4 yrs OR Master’s + 2 yrs OR Doctorate.
Preferred Qualifications / Skills:
- Degree in EE/CS, Chemical Eng, or Biotech Eng.
- PLC controls engineering/troubleshooting experience in GMP biopharma facilities and utility automation (e.g., autoclaves, parts washers, clean steam gen, WFI RO/stills, filter integrity testers, wastewater).
- Programming/design/installation/lifecycle management of standalone controls/PLC/field devices.
- Rockwell automation systems; OPC, Foundation Fieldbus, Profibus, DeviceNet integration; strong troubleshooting.
- GAMP/GMP knowledge; documentation in regulated environments (21 CFR Part 11, ASTM 2500, S88, S95).
- Capital project lifecycle management experience (design, scope/cost, business case, validation docs, execution).
- Process control strategies for NPI/new tech deployment; continuous improvement for safety/reliability/productivity.
- Self-directed team player who mentors others; strong leadership, technical writing, and communication.
Application Instructions:
- Apply at careers.amgen.com.
Responsibilities:
- Provide automation technical leadership for GMP Drug Substance Plant Operations.
- Develop and maintain automation solutions using PLCs (Allen Bradley, Siemens, etc.) and Emerson DeltaV integration.
- Develop and maintain SCADA, Trailblazer reporting, equipment PLCs, and interface hardware.
- Lead/support standalone system implementation and start-up; guide control panel/HMI layout and design (power distribution, grounding, I/O assignments).
- Partner with process SMEs to translate process requirements into digital automated solutions.
- Lead continuous improvement/innovation for standalone system efficiency and sustainability.
- Synthesize requirements to deliver automation solutions that improve workflow and productivity.
- Document delivered solutions; support computerized systems validation in a GxP environment and maintain Data Integrity Assessments.
- Build business processes aligned to project scope/timelines; develop engineering policies/procedures across organizations.
- Ongoing ops: lead functional/capital projects integrating new drug substance manufacturing technologies; perform root cause analysis, incident investigations, troubleshooting; support NPI/technology introductions; provide 24x7 onsite/on-call support, maintenance, and spare parts management.
Basic Qualifications:
- High School Diploma/GED + 10 yrs engineering OR Associate’s + 8 yrs OR Bachelor’s + 4 yrs OR Master’s + 2 yrs OR Doctorate.
Preferred Qualifications / Skills:
- Degree in EE/CS, Chemical Eng, or Biotech Eng.
- PLC controls engineering/troubleshooting experience in GMP biopharma facilities and utility automation (e.g., autoclaves, parts washers, clean steam gen, WFI RO/stills, filter integrity testers, wastewater).
- Programming/design/installation/lifecycle management of standalone controls/PLC/field devices.
- Rockwell automation systems; OPC, Foundation Fieldbus, Profibus, DeviceNet integration; strong troubleshooting.
- GAMP/GMP knowledge; documentation in regulated environments (21 CFR Part 11, ASTM 2500, S88, S95).
- Capital project lifecycle management experience (design, scope/cost, business case, validation docs, execution).
- Process control strategies for NPI/new tech deployment; continuous improvement for safety/reliability/productivity.
- Self-directed team player who mentors others; strong leadership, technical writing, and communication.
Application Instructions:
- Apply at careers.amgen.com.