Senior Manufacturing Systems Engineer (DeltaV/PLC)

About the role

Amgen's Manufacturing & Clinical Supplies - Facilities & Engineering (MCS-F&E) Automation team is looking for a Senior Manufacturing Systems Engineer to support Clinical and Commercial Drug Substance plant operations. The role covers complex automation initiatives requiring knowledge of automation platforms, integration between them, analytical problem solving, project management, lifecycle management and Operational Excellence.

Key responsibilities

• Develop and maintain process control automation solutions using DeltaV DCS, Rockwell PLC, HMI and SCADA systems
• Lead and support root cause analysis, incident investigations and troubleshooting of process control issues
• Own change control, CAPA and deviation records for automation systems
• Support projects improving process equipment, cleaning systems and utilities, and introduce new automation technologies through engineering assessments and qualification runs
• Run continuous improvement initiatives covering safety, reliability, efficiency and environmental sustainability
• Maintain data integrity assessments and support Review by Exception (batch records, cleaning, sterilization, audit trails)
• Collaborate with the Drug Substance Plant network to improve automation design
• Provide day-to-day operational support, including 24x7 on-call rotation for critical operations, troubleshooting, OS security patching and hotfix rollouts, preventive and corrective maintenance, and spare parts management
• Support regulatory inspections and audits, equipment validation and compliance with 21 CFR Part 11, S88, S95 and GAMP

Required profile

• Doctorate, or Master's degree with 3 years, Bachelor's with 5 years, Associate with 8 years, or high school diploma with 10 years of manufacturing automation engineering experience
• Preferred: hands-on experience developing process control strategies in Drug Substance plants, familiarity with upstream and downstream unit operations, and experience with continuous improvement and capital project lifecycle management
• Self-directed, able to mentor engineers, with strong leadership, technical writing and communication skills

Required skills

• Emerson Delta-V DCS and Rockwell SCADA and PLC platform
• Electronic batch reporting systems, process control network design and virtual infrastructure
• System integration with OPC, Profibus, Serial VIM, Ethernet and DeviceNet
• Compliance with 21 CFR Part 11, S88, S95 and GAMP

What we offer

• Annual salary range posted, with a discretionary bonus or sales-based incentive depending on role
• Health, dental and vision coverage, life and disability insurance, retirement savings plan and flexible spending accounts
• Stock-based long-term incentives, time-off plans and flexible work models where possible