Manufacturing Systems Engineer: Automation - PLC

About the role

Join Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

As a Manufacturing Systems Engineer, you will work with a group of automation engineers responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this role, you will collaborate with the capital project team to deliver robust automation systems to operate the new plant utility and standalone systems.

Responsibilities

• Develop and maintain automation solutions using various PLCs such as Allen Bradley, Siemens, and integration with the Emerson DeltaV system.
• Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLCs and interface hardware.
• Support standalone system implementation and start-up, including technical guidance in control panel/Human Machine Interfaces (HMI) layout and design (power distribution, grounding requirements, I/O assignments, etc.).
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Assist in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems.
• Collaborate with business partners to understand how standalone systems can improve workflow and productivity; synthesize requirements to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments with current Amgen and industry standards.
• Build business processes to support project scope in alignment with project timelines; develop detailed specifications and engineering policies.
• Support functional area projects focused on improving process equipment/utilities/facilities and large/sophisticated capital projects integrating 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 introductions by performing automation engineering assessments and implementing automation system configuration changes.
• Assist with day-to-day operational support, including 24x7 onsite/on-call support, troubleshooting, preventative and corrective maintenance, and automation system spare parts management.
• Explore innovative ways to improve business processes, enhance efficiency, and reduce costs.

Requirements

• High School Diploma/GED and 8 years of Engineering experience OR
• Associate’s Degree and 6 years of Engineering experience OR
• Bachelor’s Degree and 2 years of Engineering experience OR
• Master’s Degree

Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering.
• Direct knowledge of PLC design, controls engineering, and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation (e.g., autoclaves, parts washers, clean steam generators, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems).
• 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, including sophisticated troubleshooting, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Ability to interpret and apply GAMPs and GMPs; familiarity with documentation in a highly regulated environment (e.g., 21 CFR Part 11, ASTM 2500, S88, S95).
• Experience in Capital Project Lifecycle Management: conceptual design, scope and cost estimate development, business case development, detailed design, engineering, validation documentation, and project execution.
• Hands-on experience developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Experience with continuous improvements enhancing safety, system reliability, and productivity (e.g., cycle times, reduced plant utilities usage).
• Self-directed team player ready to embrace a collaborative culture for effective decision-making.
• Strong technical writing and communication/presentation skills.

Benefits

Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards, supporting your professional and personal growth and well-being.