Manufacturing SystemsEngineer:Automation- Delta V

Responsibilities

• Develop and maintain the process control system on Emerson Delta V distributed control system (DCS).
• 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.
• Provide clear documentation for delivered solutions and processes.
• 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.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.
• Support vendor Factory Acceptance Testing (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.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Own and drive to completion Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

Qualifications

• High School Diploma / GED and 8 years of Engineering experience OR Associates Degree and 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree Preferred.
• Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience in programming, design, installation, and lifecycle management of manufacturing process controls and automation and field instrumentation technologies.
• Experience with Emerson Delta V DCS system and ability to perform advanced troubleshooting and system integration using OPC, Foundation Fieldbus, and Profibus technologies.
• 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.
• Self-directed team player able to work cross-functionally.
• Strong technical writing and communication skills.