Senior Manufacturing Systems Engineer: Automation PLC

About the role

Be part of 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.

Responsibilities

• Provide automation technical leadership to a group of automation engineers responsible for building and maintaining automation systems and platforms that support GMP Drug Substance Plant Operations.
• Work with the capital project team to deliver robust automation systems for new plant utilities and standalone systems, including complex system automation initiatives that require strong understanding of automation platforms, integration between platforms, analytical problem-solving, project management, lifecycle management, and Operational Excellence.
• Develop and maintain automation solutions using PLCs such as Allen Bradley and Siemens, and integration with the Emerson DeltaV system.
• Develop and maintain Supervisory Control and Data Acquisition (SCADA), Trailblazer reporting system, equipment PLCs, and interface hardware.
• Lead and support standalone system implementation and start-up; participate in control panel and Human Machine Interface (HMI) layout and design, including power distribution, grounding requirements, and I/O assignments.
• Collaborate with process subject matter experts to translate key process requirements into digital automated solutions.
• Lead continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems.
• Collaborate with business partners to improve workflow and productivity through automation solutions; synthesize requirements from clients, customers, or end-users.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners to support computerized systems validation in a GxP environment.
• Maintain data integrity assessments aligned with current Amgen and industry standards.
• Build business processes to support project scope in alignment with project timelines; develop detailed specifications and engineering policies and procedures affecting multiple organizational units.
• Lead and support functional area projects focused on improving process equipment, utilities, facilities, and large capital projects to integrate new drug substance manufacturing technologies.
• Lead technical root cause analysis, incident investigations, and troubleshooting on standalone systems.
• Support new product or technology introductions by performing automation engineering assessments, implementing configuration changes, and supporting engineering and process qualification runs.
• Provide day-to-day operational support including 24x7 onsite/on-call support, troubleshooting, preventative and corrective maintenance, and automation system spare parts management.

Requirements

• 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

Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering.
• Direct knowledge of PLC design and experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation, including autoclaves, parts washers, clean steam generators, WFI pretreatment RO, WFI stills, filter integrity testers, and wastewater treatment systems.
• Extensive understanding and background in 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; system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Ability to interpret and apply GAMP and GMP requirements; familiarity with documentation in a highly regulated environment including 21 CFR Part 11, ASTM E2500, S88, and S95.
• Experience in Capital Project Lifecycle Management: conceptual design, scope and cost estimate development, business case development, detailed design, engineering and 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 resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, reduced plant utilities usage) related to Drug Substance Plant Operations.
• Self-directed team player ready to mentor and develop engineering staff; embraces a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.