Manufacturing Systems Engineer: Automation (Swing Shift Monday - Friday)
Amgen
17 days ago
On-site
Holly Springs, NC
Operations
Manufacturing Systems Engineer: Automation
Responsibilities:
- Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
- Collaborate with stakeholders and end-users to synthesize process requirements and develop solutions using Amgen’s 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 ensure design aligns with Amgen specifications, latest 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 efforts, 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.
- Support functional area and capital projects integrating new drug substance manufacturing technologies.
- Drive continuous improvement to improve workflows, 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 and 8 years engineering experience OR Associate’s degree and 6 years OR Bachelor’s and 2 years OR Master’s degree.
Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- Process control engineering/troubleshooting experience in GMP biopharmaceutical automation (e.g., media, harvest, bioreactors, solution prep, single-use mixing, chromatography, TFF, viral filtration/inactivation, UF/DF, depth filtration, CIP/SIP, clean utilities, OEM automation).
- Experience programming/installation/lifecycle management of automation and field instrumentation.
- Experience with Emerson DeltaV DCS; advanced troubleshooting; integration using OPC, Foundation Fieldbus, Profibus.
- Ability to interpret/apply GAMPs and GMPs; documentation experience in regulated environments (21 CFR Part 11, ASTM 2500, S88, S95).
- Self-directed, cross-functional team player; strong technical writing and communication.
Work Schedule:
- Swing Shift: 3pm–11pm, Monday–Friday.
Benefits (as stated): Retirement and Savings Plan (company contributions), medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus, stock-based long-term incentives, time-off and bi-annual shutdowns, flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com.
Responsibilities:
- Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
- Collaborate with stakeholders and end-users to synthesize process requirements and develop solutions using Amgen’s 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 ensure design aligns with Amgen specifications, latest 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 efforts, 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.
- Support functional area and capital projects integrating new drug substance manufacturing technologies.
- Drive continuous improvement to improve workflows, 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 and 8 years engineering experience OR Associate’s degree and 6 years OR Bachelor’s and 2 years OR Master’s degree.
Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- Process control engineering/troubleshooting experience in GMP biopharmaceutical automation (e.g., media, harvest, bioreactors, solution prep, single-use mixing, chromatography, TFF, viral filtration/inactivation, UF/DF, depth filtration, CIP/SIP, clean utilities, OEM automation).
- Experience programming/installation/lifecycle management of automation and field instrumentation.
- Experience with Emerson DeltaV DCS; advanced troubleshooting; integration using OPC, Foundation Fieldbus, Profibus.
- Ability to interpret/apply GAMPs and GMPs; documentation experience in regulated environments (21 CFR Part 11, ASTM 2500, S88, S95).
- Self-directed, cross-functional team player; strong technical writing and communication.
Work Schedule:
- Swing Shift: 3pm–11pm, Monday–Friday.
Benefits (as stated): Retirement and Savings Plan (company contributions), medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus, stock-based long-term incentives, time-off and bi-annual shutdowns, flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com.