Senior Manufacturing Systems Engineer: Automation - DeltaV
Amgen
Full-time
Remote friendly (Holly Springs, NC)
United States
Operations
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Role Summary
Senior Manufacturing Systems Engineer: Automation - DeltaV. Provide automation technical leadership to a group of automation engineers responsible for building and maintaining automation systems and platforms supporting GMP Drug Substance Plant Operations. Work with the capital project team to deliver robust process automation systems to operate the new plant.
Responsibilities
- Collaborate with key stakeholders and end-users to understand process requirements and develop solutions using Amgen standard automation platform for process automation systems
- Support design phases to ensure alignment with specifications, latest technology, and safety requirements
- Support vendor FAT to ensure control strategy and software code meet Amgen requirements
- Develop and maintain engineering and maintenance documentation and procedures for delivered solutions
- Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or strategy
- Support commissioning and qualification including Automation IV/ACO
- Support QA partners in computerized systems validation in a GxP environment
- Perform Data Integrity Assessments (DIA) per Amgen and industry standards
Site Operations
- Own and drive Change Controls, CAPAs, and Deviations
- Lead and support technical root cause analysis, incident investigations, and troubleshooting
- Lead and support projects to improve process equipment, utilities, facilities, and large capital projects for integrating new drug substance technologies
- Drive continuous improvement for process automation systems to enhance safety, reliability, efficiency, and sustainability
- Support day-to-day operations including rotational on-call
- Perform and maintain Data Integrity Assessments (DIA) per Amgen and industry standards
Qualifications
- Basic Qualifications:
- High School diploma/GED and 10 years of engineering experience OR
- Associate’s degree and 8 years of engineering experience OR
- Bachelor’s degree and 4 years of engineering experience OR
- Master’s degree and 2 years of engineering experience OR
- Doctorate degree
- Preferred Qualifications:
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
- Direct knowledge of automation system design
- Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
- Experience in automation of GMP biopharmaceutical equipment and systems (e.g., buffer prep, chromatography, single-use vessels, depth filtration, solution prep)
- Experience in integrating various OEM automation software
- Experience in programming, design, installation, and lifecycle management of manufacturing process controls and field instrumentation technologies
- Experience with Emerson DeltaV DCS, advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus
- Ability to interpret and apply GAMPs and GMPs; familiarity with 21 CFR Part 11, ASTM 2500, S88, S95
- Self-directed team player capable of cross-functional work
- Strong leadership, technical writing, and communication skills
- Ability for domestic and international travel
Skills
- Process automation systems
- DeltaV DCS and related integration technologies
- GxP validation and IQ/OQ/PQ processes
- Data Integrity and compliance tooling
- Technical writing and documentation
Education
- As per qualifications above (degree in relevant engineering or related field)
Additional Requirements
- Domestic and international travel as required