Senior Manufacturing Systems Engineer: Automation

Role Summary

Senior Manufacturing Systems Engineer, Automation. You will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining automation systems and platforms that support GMP Drug Substance Plant Operations. You will work closely with the capital project team to deliver robust process automation systems to operate the new plant as part of the Facilities & Engineering Automation team.

Responsibilities

• Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
• Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
• Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
• Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
• Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
• Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
• Support QA partners in performing computerized systems validation in a GxP environment
• Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
• Own and drive to completion Change Controls, CAPAs, and Deviations
• Lead and support technical root cause analysis, incident investigations, and troubleshooting
• Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
• Support day-to-day operations including rotational on-call support
• Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards

Qualifications

• Required: 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: Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
• Preferred: Direct knowledge of automation system design
• Preferred: Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
• Preferred: Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
• Preferred: Experience in integrating various OEM automation software
• Preferred: Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies
• Preferred: Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
• Preferred: Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
• Preferred: Self-directed team player able to work cross-functionally
• Preferred: Strong leadership, technical writing, and communication skills
• Preferred: Ability for domestic and international travel

Skills

• 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 such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
• Experience in integrating various OEM automation software
• Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies
• Experience with Emerson DeltaV DCS system and system integration using OPC, Foundation Fieldbus, and Profibus technologies
• Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
• Self-directed team player able to work cross-functionally
• Strong leadership, technical writing, and communication skills
• Travel availability for domestic and international assignments