Senior Manager Manufacturing Systems Engineering - Automation
Amgen
12 hours ago
On-site
Holly Springs, NC
Operations
Senior Manager Manufacturing Systems Engineering - Automation
What You Will Do
- Lead a team of Automation Engineers and serve as the main point of contact for automation for ANC 1 manufacturing (Allen Bradley PLCs, Siemens Desigo CC, Emerson DeltaV).
- Define, drive, and deliver the automation and process control strategy for Drug Substance manufacturing.
- Provide 24x7 operational support: mentoring, staff development, team productivity, and resource use.
- Develop support structures with internal/multi-functional teams for capital projects and plant support.
- Advise senior management; align automation development with Amgen Process Development strategy.
- Maintain/improve automation reliability; focus on “Maintenance Excellence,” failure prevention, and recurrence avoidance.
- Drive continuous improvements by translating business needs into engineering solutions; lead analysis of alternatives.
- Ensure compliance and site readiness for internal/external/partner audits.
- Ensure personnel safety during plant operations and engineering activities.
- Develop expense budget forecasts; hold accountability for operational/capital budgets.
- Maintain enterprise cyber resiliency compliance and ensure 100% right-first-time quality compliance.
- Ensure reporting for batch records, cleaning, sterilization systems (audit trail/version control).
- Establish OEM service contracts and service coverage.
- Ensure automation staff training and adherence to GMP standards and procedures.
- Ensure participation in Work Center Team (WCT) meetings and support key projects.
What We Expect Of You
Basic Qualifications:
- High school/GED with 12+ years; OR Associate’s with 10+; OR Bachelor’s with 8+; OR Master’s with 6+; OR Doctorate with 2+ years in Engineering and/or Project Management.
- Minimum 2 years directly managing people or leading teams/projects/resources.
Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- Emerson DeltaV, Siemens Desigo CC, Allen Bradley PLC; advanced troubleshooting and integration (OPC, Foundation Fieldbus, Profibus).
- Knowledge of automation system design; programming/installation/lifecycle management.
- Automation of GMP biopharmaceutical equipment (e.g., buffer prep/hold, chromatography, single-use mixing, depth filtration, solution prep).
- Familiarity with GAMPs/GMPs and regulated documentation (e.g., 21 CFR Part 11, ASTM 2500, S88, S95).
Benefits (explicitly stated)
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending).
- Discretionary annual bonus.
- Stock-based long-term incentives.
- Time-off plans and bi-annual shutdowns.
- Flexible work models/remote where possible.
Application Instructions
- Apply now at careers.amgen.com.
What You Will Do
- Lead a team of Automation Engineers and serve as the main point of contact for automation for ANC 1 manufacturing (Allen Bradley PLCs, Siemens Desigo CC, Emerson DeltaV).
- Define, drive, and deliver the automation and process control strategy for Drug Substance manufacturing.
- Provide 24x7 operational support: mentoring, staff development, team productivity, and resource use.
- Develop support structures with internal/multi-functional teams for capital projects and plant support.
- Advise senior management; align automation development with Amgen Process Development strategy.
- Maintain/improve automation reliability; focus on “Maintenance Excellence,” failure prevention, and recurrence avoidance.
- Drive continuous improvements by translating business needs into engineering solutions; lead analysis of alternatives.
- Ensure compliance and site readiness for internal/external/partner audits.
- Ensure personnel safety during plant operations and engineering activities.
- Develop expense budget forecasts; hold accountability for operational/capital budgets.
- Maintain enterprise cyber resiliency compliance and ensure 100% right-first-time quality compliance.
- Ensure reporting for batch records, cleaning, sterilization systems (audit trail/version control).
- Establish OEM service contracts and service coverage.
- Ensure automation staff training and adherence to GMP standards and procedures.
- Ensure participation in Work Center Team (WCT) meetings and support key projects.
What We Expect Of You
Basic Qualifications:
- High school/GED with 12+ years; OR Associate’s with 10+; OR Bachelor’s with 8+; OR Master’s with 6+; OR Doctorate with 2+ years in Engineering and/or Project Management.
- Minimum 2 years directly managing people or leading teams/projects/resources.
Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- Emerson DeltaV, Siemens Desigo CC, Allen Bradley PLC; advanced troubleshooting and integration (OPC, Foundation Fieldbus, Profibus).
- Knowledge of automation system design; programming/installation/lifecycle management.
- Automation of GMP biopharmaceutical equipment (e.g., buffer prep/hold, chromatography, single-use mixing, depth filtration, solution prep).
- Familiarity with GAMPs/GMPs and regulated documentation (e.g., 21 CFR Part 11, ASTM 2500, S88, S95).
Benefits (explicitly stated)
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending).
- Discretionary annual bonus.
- Stock-based long-term incentives.
- Time-off plans and bi-annual shutdowns.
- Flexible work models/remote where possible.
Application Instructions
- Apply now at careers.amgen.com.