Senior Manufacturing Systems Engineer: Automation - BAS / PLC
Amgen
August 25, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Senior Manufacturing Systems Engineer: Automation - BAS / PLC
What You Will Do
Provide automation technical leadership for building and maintaining automation systems and platforms supporting GMP Drug Substance Plant Operations. Deliver building automation systems (BAS) and PLC-based process and utility skid equipment for a new plant.
Responsibilities
- Site design, construction, start-up, and operational readiness: collaborate on process requirements; develop automation solutions using Amgen standard platforms; maintain engineering/maintenance documentation and procedures; support computerized systems validation in a GxP environment; maintain Data Integrity Assessments.
- Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
- Develop commissioning/qualification plans/strategies with cross-functional teams.
- Ensure standalone PLC systems have proper network connectivity for centralized monitoring/alarming.
- Support design to align with specifications, technology, and safety requirements.
- Lead vendor FAT and ensure control strategy/software code meet Amgen requirements.
- Ensure control strategy aligns with manufacturing operations, including retrofit projects.
- Site operations: act as system owner (BAS and standalone PLCs) for system administration, maintenance procedures, job plans, spare parts, and engineering documentation.
- Drive Change Controls, CAPAs, and Deviations to completion; lead/support projects for process/utility/facilities improvements and capital projects.
- Drive continuous improvement for safety, reliability, efficiency, and sustainability; perform root cause analysis, incident investigations, troubleshooting.
- Provide day-to-day operational support and rotational on-call.
- Perform and maintain data integrity assessments.
What We Expect Of You
Basic Qualifications:
- High School Diploma/GED + 10 years engineering experience OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications/Skills:
- Degree in Electrical Engineering/Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- BMS design knowledge; building control engineering troubleshooting in GMP biopharmaceutical facilities; integration of OEM automation software.
- Experience with BAS and process/utility skid equipment; OEM software and field instrumentation integration.
- Knowledge of 21 CFR Part 11, ASTM 2500, S95, GAMP 5, GDP.
- Experience programming, design, installation, and lifecycle management of building automation controls, PLCs, and field devices/instrumentation.
- Ability to interpret/apply GAMPs/GMPs and documentation practices in regulated environments.
- Self-directed, cross-functional team player; strong leadership, technical writing, communication/presentation; travel as needed.
Benefits (as described)
- Total Rewards Plan (health/welfare, retirement/savings, bonus, stock-based incentives, time-off, and flexible remote/hybrid work where possible).
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient number received or a candidate is selected.
What You Will Do
Provide automation technical leadership for building and maintaining automation systems and platforms supporting GMP Drug Substance Plant Operations. Deliver building automation systems (BAS) and PLC-based process and utility skid equipment for a new plant.
Responsibilities
- Site design, construction, start-up, and operational readiness: collaborate on process requirements; develop automation solutions using Amgen standard platforms; maintain engineering/maintenance documentation and procedures; support computerized systems validation in a GxP environment; maintain Data Integrity Assessments.
- Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
- Develop commissioning/qualification plans/strategies with cross-functional teams.
- Ensure standalone PLC systems have proper network connectivity for centralized monitoring/alarming.
- Support design to align with specifications, technology, and safety requirements.
- Lead vendor FAT and ensure control strategy/software code meet Amgen requirements.
- Ensure control strategy aligns with manufacturing operations, including retrofit projects.
- Site operations: act as system owner (BAS and standalone PLCs) for system administration, maintenance procedures, job plans, spare parts, and engineering documentation.
- Drive Change Controls, CAPAs, and Deviations to completion; lead/support projects for process/utility/facilities improvements and capital projects.
- Drive continuous improvement for safety, reliability, efficiency, and sustainability; perform root cause analysis, incident investigations, troubleshooting.
- Provide day-to-day operational support and rotational on-call.
- Perform and maintain data integrity assessments.
What We Expect Of You
Basic Qualifications:
- High School Diploma/GED + 10 years engineering experience OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications/Skills:
- Degree in Electrical Engineering/Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- BMS design knowledge; building control engineering troubleshooting in GMP biopharmaceutical facilities; integration of OEM automation software.
- Experience with BAS and process/utility skid equipment; OEM software and field instrumentation integration.
- Knowledge of 21 CFR Part 11, ASTM 2500, S95, GAMP 5, GDP.
- Experience programming, design, installation, and lifecycle management of building automation controls, PLCs, and field devices/instrumentation.
- Ability to interpret/apply GAMPs/GMPs and documentation practices in regulated environments.
- Self-directed, cross-functional team player; strong leadership, technical writing, communication/presentation; travel as needed.
Benefits (as described)
- Total Rewards Plan (health/welfare, retirement/savings, bonus, stock-based incentives, time-off, and flexible remote/hybrid work where possible).
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient number received or a candidate is selected.