Senior Manufacturing Systems Engineer: Automation (Swing Shift Monday - Friday)
Amgen
17 days ago
On-site
Holly Springs, NC
Operations
Senior Manufacturing Systems Engineer: Automation (Swing Shift 3pm–11pm, Mon–Fri)
What You Will Do
- Provide automation technical leadership for GMP Drug Substance Plant Operations.
- Deliver robust process automation systems for a new plant; integrate multiple automation platforms using analytical problem-solving, project/lifecycle management, and Operational Excellence.
Responsibilities
- Develop and maintain Emerson DeltaV DCS process control systems.
- Translate process SME requirements into digital automated solutions.
- Collaborate to improve workflow/productivity; synthesize end-user/client requirements.
- Document solutions and support computerized systems validation (GxP); maintain Data Integrity Assessments.
- Build business processes aligned to project timelines; develop detailed specifications/policies across organizational units.
- Support commissioning/qualification including Automation IV/ACO.
- Own Change Controls, CAPAs, and Deviations.
- Lead/support projects integrating new drug substance manufacturing technologies.
- Perform root-cause analysis, incident investigations, and troubleshooting.
- Support NPI/new technology introductions via automation assessments, configuration changes, and qualification runs.
- Provide 24x7 onsite/on-call operational support; troubleshooting, system admin, preventive/corrective maintenance, and spare parts management.
- Prepare/review SOPs and cGMP documents.
Basic Qualifications
- High School/GED + 10 yrs OR Associate + 8 yrs OR Bachelor + 4 yrs OR Master + 2 yrs OR Doctorate.
Preferred Qualifications / Skills
- Degree in EE, CS, Chemical, Biotech, or related field.
- GMP biopharma automation/process control/troubleshooting experience (e.g., media, harvest, bioreactors, chromatography, TFF/TFFX, viral filtration/inactivation, UF/DF, depth filtration, fill, CIP/SIP, clean utilities).
- Programming/design/installation/lifecycle management of controls and instrumentation.
- Emerson DeltaV DCS; process control network segregation/virtual infrastructure; OPC/FF/Profibus/DeviceNet; DeltaV Live preferred.
- GAMP/GMP + regulated documentation (21 CFR Part 11, ASTM 2500, S88, S95).
- Capital project lifecycle management; process control strategies for NPI/technology deployment; continuous improvement for safety/reliability/productivity.
- Self-directed team player; mentor/lead; strong technical writing and communication.
Benefits (Total Rewards)
- Medical/dental/vision, life/disability, retirement & savings with company contributions, flexible spending, annual bonus/incentive, stock-based long-term incentives, time-off and bi-annual shutdowns, and flexible work models where possible.
Application
- Apply at careers.amgen.com.
What You Will Do
- Provide automation technical leadership for GMP Drug Substance Plant Operations.
- Deliver robust process automation systems for a new plant; integrate multiple automation platforms using analytical problem-solving, project/lifecycle management, and Operational Excellence.
Responsibilities
- Develop and maintain Emerson DeltaV DCS process control systems.
- Translate process SME requirements into digital automated solutions.
- Collaborate to improve workflow/productivity; synthesize end-user/client requirements.
- Document solutions and support computerized systems validation (GxP); maintain Data Integrity Assessments.
- Build business processes aligned to project timelines; develop detailed specifications/policies across organizational units.
- Support commissioning/qualification including Automation IV/ACO.
- Own Change Controls, CAPAs, and Deviations.
- Lead/support projects integrating new drug substance manufacturing technologies.
- Perform root-cause analysis, incident investigations, and troubleshooting.
- Support NPI/new technology introductions via automation assessments, configuration changes, and qualification runs.
- Provide 24x7 onsite/on-call operational support; troubleshooting, system admin, preventive/corrective maintenance, and spare parts management.
- Prepare/review SOPs and cGMP documents.
Basic Qualifications
- High School/GED + 10 yrs OR Associate + 8 yrs OR Bachelor + 4 yrs OR Master + 2 yrs OR Doctorate.
Preferred Qualifications / Skills
- Degree in EE, CS, Chemical, Biotech, or related field.
- GMP biopharma automation/process control/troubleshooting experience (e.g., media, harvest, bioreactors, chromatography, TFF/TFFX, viral filtration/inactivation, UF/DF, depth filtration, fill, CIP/SIP, clean utilities).
- Programming/design/installation/lifecycle management of controls and instrumentation.
- Emerson DeltaV DCS; process control network segregation/virtual infrastructure; OPC/FF/Profibus/DeviceNet; DeltaV Live preferred.
- GAMP/GMP + regulated documentation (21 CFR Part 11, ASTM 2500, S88, S95).
- Capital project lifecycle management; process control strategies for NPI/technology deployment; continuous improvement for safety/reliability/productivity.
- Self-directed team player; mentor/lead; strong technical writing and communication.
Benefits (Total Rewards)
- Medical/dental/vision, life/disability, retirement & savings with company contributions, flexible spending, annual bonus/incentive, stock-based long-term incentives, time-off and bi-annual shutdowns, and flexible work models where possible.
Application
- Apply at careers.amgen.com.