Manufacturing Systems Engineer: Automation - PLC

About This Role

As a Manufacturing Systems Engineer specializing in Automation and PLCs at Amgen, you will develop and maintain robust automation systems for a new GMP Drug Substance Plant, integrating advanced technologies and ensuring operational excellence.

Responsibilities

• Develop and maintain automation solutions using various PLCs (e.g., Allen Bradley, Siemens) and integrate with Emerson DeltaV system
• Develop and maintain Supervisory Control and Data Acquisition (SCADA) system, Trailblazer reporting, and equipment PLCs and interface hardware
• Support standalone system implementation and start-up, providing technical guidance on control panel/HMI layout and design
• Work with process subject matter experts (SMEs) to translate process requirements into digital automated solutions
• Assist in continuous improvement and innovation initiatives for efficient operation and sustainability of standalone systems
• Collaborate with business partners to understand workflow and productivity improvements through automation solutions, synthesizing requirements from clients and end-users
• Provide clear documentation for delivered solutions and processes, working with QA partners on computerized systems validation in a GxP environment
• Maintain Data Integrity Assessments in alignment with Amgen and Industry standards
• Build business processes to support project scope and timeline, developing detailed specifications and engineering policies
• Support functional area projects improving process equipment/utilities/facilities and large capital projects for new drug substance manufacturing technologies
• Support technical root cause analysis, incident investigations, and troubleshooting on standalone systems
• Support new product introductions (NPI) or new technology deployments by performing automation engineering assessments and implementing system configuration changes
• Assist with Day-to-Day Operational Support (24x7 onsite/on-call, troubleshooting, maintenance, spare parts management)

Requirements

• Experience developing and maintaining automation solutions using various PLCs (e.g., Allen Bradley, Siemens)
• Experience with integration with Emerson DeltaV system
• Experience developing and maintaining Supervisory Control and Data Acquisition system (SCADA)
• Experience with Trailblazer reporting system
• Experience with equipment PLCs and interface hardware
• Ability to support standalone system implementation and start-up
• Ability to provide technical guidance in control panel / Human Machine Interfaces (HMI) layout and design
• Experience with process subject matter experts (SMEs) to transform requirements into digital automated solutions
• Experience with computerized systems validation processes in a GxP environment
• Knowledge of Data Integrity Assessments with Amgen and Industry standards

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
• 8 years of Engineering experience with High School Diploma/GED, 6 years with Associate's, or 2 years with Bachelor's, or Master's Degree

Nice to Have

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering
• Direct knowledge of PLC design, controls engineering, troubleshooting in GMP biopharmaceutical production facilities
• Extensive understanding of programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
• Experience with Rockwell industrial automation hardware and systems
• Ability to perform sophisticated troubleshooting activities
• Experience with System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
• Ability to interpret and apply GAMPs and GMPs
• Familiarity with 21 CFR Part 11, ASTM 2500, S88, S95
• Experience in Capital Project Lifecycle Management
• Hands-on experience developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations
• Experience with continuous improvements in safety, system reliability, and productivity
• Strong technical writing and communication/presentation skills

Skills

* Required skills

Benefits