Senior Manufacturing Systems Engineer - Downstream Automation (DeltaV)

About the role

Amgen is hiring a Senior Manufacturing Systems Engineer for its new drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with stainless steel equipment and embeds Industry 4.0 capabilities. You will lead automation engineers in building and maintaining automation systems that support GMP drug substance plant operations, working with the capital project team to deliver robust process automation systems.

Key responsibilities

• Develop and maintain the process control system on the Emerson DeltaV distributed control system (DCS)
• Translate process requirements from SMEs and customers into digital automated solutions, and document them clearly
• Support computerized systems validation in a GxP environment and maintain Data Integrity Assessments
• Build business processes, specifications and engineering policies, and support commissioning and qualification including IV/ACO
• Own Change Controls, CAPAs and deviations, and lead root cause analysis, incident investigations and troubleshooting
• Support new product and technology introductions, and handle day-to-day operational support including 24x7 on-call, preventive and corrective maintenance, system administration and spare parts management
• Prepare and review SOPs and cGMP documents, and propose improvements to process equipment, utilities and facilities

Required profile

• Basic: high school diploma or GED and 10 years of engineering experience, or associate's degree and 8 years, or bachelor's degree and 4 years, or master's degree and 2 years of engineering experience
• Preferred: degree in electrical, computer, chemical or biotech engineering
• Ability to interpret GAMPs and GMPs, and familiarity with 21 CFR Part 11, ASTM 2500, S88 and S95
• Experience in capital project lifecycle management and continuous improvement in drug substance plant operations
• Self-directed team player ready to mentor engineering staff, with strong leadership, technical writing and presentation skills

Required skills

• Emerson DeltaV DCS, Process Control Network design and troubleshooting, and DeltaV Live (preferred)
• Integration using OPC, Foundation Fieldbus, Profibus and DeviceNet
• Hands-on experience with GMP biopharmaceutical automation such as media, harvest, bioreactors, chromatography, TFFL/TFFX, viral filtration, UF/DF, drug substance fill, CIP/SIP and clean utilities
• Programming, design, installation and lifecycle management of process controls and field instrumentation