Senior Manufacturing Systems Engineer: Automation (Wednesday - Saturday Shift)
Amgen
17 days ago
On-site
Holly Springs, NC
Operations
Senior Manufacturing Systems Engineer: Automation (GMP Drug Substance Plant Operations)
What You Will Do / Responsibilities:
- Provide automation technical leadership to build and maintain automation systems and platforms supporting GMP plant operations.
- Develop and maintain process control on Emerson DeltaV distributed control system (DCS).
- Translate process requirements from SMEs into digital automation solutions.
- Collaborate with business partners to improve workflow/productivity; synthesize end-user/client requirements.
- Document delivered solutions; support computerized systems validation in a GxP environment and maintain Data Integrity Assessments.
- Develop business processes, detailed specifications, and engineering policies/procedures aligned to project scope and timelines.
- Support commissioning and qualification (Automation Installation Verification/Automation Check Out).
- Own Change Controls, CAPAs, and Deviations.
- Lead/support projects and root-cause analysis for process control issues; troubleshoot incidents.
- Support NPI/new technology introductions (automation assessments, configuration changes, and qualification runs).
- Provide day-to-day 24x7 onsite/on-call operational support (troubleshooting, preventive/corrective maintenance, administration, spare parts).
- Prepare/review SOPs and cGMP documents.
What We Expect (Basic Qualifications):
- High School/GED + 10 yrs engineering OR Associate + 8 OR Bachelor + 4 OR Master + 2 OR Doctorate.
Preferred Qualifications / Required Skills:
- Degree in EE/CS/ChemE/Biotech or related.
- Process control/automation design & troubleshooting in GMP biopharmaceutical facilities (e.g., bioreactors, chromatography, UF/DF, filtration, CIP/SIP, clean utilities).
- Programming; design/installation/lifecycle management of manufacturing controls and field instrumentation.
- Emerson DeltaV DCS; network segregation/virtual infrastructure; OPC/FF/Profibus/DeviceNet; DeltaV Live preferred.
- GAMP/GMP, 21 CFR Part 11, ASTM 2500, S88, S95; capital project lifecycle experience; NPI/new technology deployment; continuous improvement mindset.
Benefits (Total Rewards):
- Comprehensive medical/dental/vision; life/disability; retirement & savings with company contributions; flexible spending; annual bonus; stock-based incentives; time-off and bi-annual shutdowns; flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com.
What You Will Do / Responsibilities:
- Provide automation technical leadership to build and maintain automation systems and platforms supporting GMP plant operations.
- Develop and maintain process control on Emerson DeltaV distributed control system (DCS).
- Translate process requirements from SMEs into digital automation solutions.
- Collaborate with business partners to improve workflow/productivity; synthesize end-user/client requirements.
- Document delivered solutions; support computerized systems validation in a GxP environment and maintain Data Integrity Assessments.
- Develop business processes, detailed specifications, and engineering policies/procedures aligned to project scope and timelines.
- Support commissioning and qualification (Automation Installation Verification/Automation Check Out).
- Own Change Controls, CAPAs, and Deviations.
- Lead/support projects and root-cause analysis for process control issues; troubleshoot incidents.
- Support NPI/new technology introductions (automation assessments, configuration changes, and qualification runs).
- Provide day-to-day 24x7 onsite/on-call operational support (troubleshooting, preventive/corrective maintenance, administration, spare parts).
- Prepare/review SOPs and cGMP documents.
What We Expect (Basic Qualifications):
- High School/GED + 10 yrs engineering OR Associate + 8 OR Bachelor + 4 OR Master + 2 OR Doctorate.
Preferred Qualifications / Required Skills:
- Degree in EE/CS/ChemE/Biotech or related.
- Process control/automation design & troubleshooting in GMP biopharmaceutical facilities (e.g., bioreactors, chromatography, UF/DF, filtration, CIP/SIP, clean utilities).
- Programming; design/installation/lifecycle management of manufacturing controls and field instrumentation.
- Emerson DeltaV DCS; network segregation/virtual infrastructure; OPC/FF/Profibus/DeviceNet; DeltaV Live preferred.
- GAMP/GMP, 21 CFR Part 11, ASTM 2500, S88, S95; capital project lifecycle experience; NPI/new technology deployment; continuous improvement mindset.
Benefits (Total Rewards):
- Comprehensive medical/dental/vision; life/disability; retirement & savings with company contributions; flexible spending; annual bonus; stock-based incentives; time-off and bi-annual shutdowns; flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com.