Senior Manufacturing Systems Engineer: Automation - PLC

Amgen; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Manufacturing Systems Engineer focused on automation PLCs to lead GMP drug substance operations. You will design, implement, and support PLC/SCADA/HMI solutions and guide validation for regulated environments.

Role requires strong leadership, cross-functional collaboration with process SMEs, and ongoing improvements across projects with on-site support in a fast-paced biopharma setting.

Qualifications

• Experience in GMP biopharma facilities preferred.
• Controls engineering and troubleshooting across PLC/SCADA.
• Lifecycle management of standalone controls/field devices.

Responsibilities

• Lead automation system projects and startup.
• Validate computerized systems in GxP.
• Provide 24x7 on-site/on-call support.
• Mentor team and drive continuous improvements.

Skills

PLC controls

Rockwell Automation

Siemens

GxP compliance

Data integrity

Leadership

Education

Bachelor's in EE/CS

Chemical Engineering

Biotech Engineering

Tools

Emerson DeltaV

SCADA systems

HMI development

OPC/Fieldbus

Job description

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.