Manufacturing Systems Engineer: Automation (Sunday - Wednesday Shift)
Amgen
11 hours ago
On-site
Holly Springs, NC
Operations
Manufacturing Systems Engineer: Automation
Schedule: 4 days x 10 hr shift (Sunday through Wednesday).
Responsibilities:
- Develop and maintain process control on the Emerson DeltaV distributed control system (DCS).
- Collaborate with stakeholders/end-users to synthesize process requirements and develop solutions using Amgen standard automation platform.
- Provide clear documentation for delivered solutions and processes.
- Support QA partners with computerized systems validation in a GxP environment.
- Perform Data Integrity Assessments (DIA) per Amgen and industry standards.
- Support process automation systems to align with Amgen specifications, technology, and safety requirements.
- Support vendor FAT to ensure control strategy and software code meet Amgen requirements.
- Develop and maintain engineering/maintenance documentation and procedures.
- Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
- Own and drive Change Controls, CAPAs, and Deviations to completion.
- Support technical root cause analysis, incident investigations, and troubleshooting.
- Drive continuous improvement for safety, reliability, efficiency, and sustainability.
- Support day-to-day operations including rotational on-call support.
- Prepare/review SOPs and cGMP documents.
Basic Qualifications:
- High School Diploma/GED + 8 years engineering OR Associate’s + 6 years OR Bachelor’s + 2 years OR Master’s.
Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related.
- Automation system design and GMP biopharmaceutical production process control/troubleshooting experience (e.g., media/harvest/bioreactors, chromatography, TFF, viral filtration/inactivation, UF/DF, CIP/SIP, clean utilities; OEM automation software).
- Programming, installation, and lifecycle management of automation and field instrumentation.
- Emerson DeltaV DCS experience; advanced troubleshooting; system integration using OPC, Foundation Fieldbus, Profibus.
- Ability to interpret/apply GAMPs and GMPs; regulated documentation familiarity (e.g., 21 CFR Part 11, ASTM 2500, S88, S95).
- Self-directed, cross-functional team player; strong technical writing and communication.
Benefits (if eligible): Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus, stock-based long-term incentives, time-off and shutdowns, and flexible work models (remote where possible).
Application: Apply at careers.amgen.com.
Schedule: 4 days x 10 hr shift (Sunday through Wednesday).
Responsibilities:
- Develop and maintain process control on the Emerson DeltaV distributed control system (DCS).
- Collaborate with stakeholders/end-users to synthesize process requirements and develop solutions using Amgen standard automation platform.
- Provide clear documentation for delivered solutions and processes.
- Support QA partners with computerized systems validation in a GxP environment.
- Perform Data Integrity Assessments (DIA) per Amgen and industry standards.
- Support process automation systems to align with Amgen specifications, technology, and safety requirements.
- Support vendor FAT to ensure control strategy and software code meet Amgen requirements.
- Develop and maintain engineering/maintenance documentation and procedures.
- Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
- Own and drive Change Controls, CAPAs, and Deviations to completion.
- Support technical root cause analysis, incident investigations, and troubleshooting.
- Drive continuous improvement for safety, reliability, efficiency, and sustainability.
- Support day-to-day operations including rotational on-call support.
- Prepare/review SOPs and cGMP documents.
Basic Qualifications:
- High School Diploma/GED + 8 years engineering OR Associate’s + 6 years OR Bachelor’s + 2 years OR Master’s.
Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related.
- Automation system design and GMP biopharmaceutical production process control/troubleshooting experience (e.g., media/harvest/bioreactors, chromatography, TFF, viral filtration/inactivation, UF/DF, CIP/SIP, clean utilities; OEM automation software).
- Programming, installation, and lifecycle management of automation and field instrumentation.
- Emerson DeltaV DCS experience; advanced troubleshooting; system integration using OPC, Foundation Fieldbus, Profibus.
- Ability to interpret/apply GAMPs and GMPs; regulated documentation familiarity (e.g., 21 CFR Part 11, ASTM 2500, S88, S95).
- Self-directed, cross-functional team player; strong technical writing and communication.
Benefits (if eligible): Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus, stock-based long-term incentives, time-off and shutdowns, and flexible work models (remote where possible).
Application: Apply at careers.amgen.com.