Senior Manufacturing Systems Engineer: Automation PLC

Amgen • Holly Springs, NC

29d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotechnology, focused on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. This role is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX batch facility, which combines disposable technologies with traditional equipment and integrates industry 4.0 capabilities and sustainability innovations. The facility aims to be carbon-neutral by 2027.

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
• Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering (Preferred)
• Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation (e.g., autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems).
• Experience integrating various OEM automation software.
• 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 GAMPs and GMPs.
• Familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, 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 in 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 related to Drug Substance Plant Operations.
• Self-directed team player ready to mentor and develop engineering staff.
• Embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.

Nice To Haves

• Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering.

Responsibilities

• Provide automation technical leadership to a group of automation engineers responsible for building and maintaining automation systems and platforms supporting GMP Drug Substance Plant Operations.
• Work with the capital project team to deliver robust automation systems for new plant utility and standalone systems.
• Develop and maintain automation solutions using PLCs (e.g., Allen Bradley, Siemens) and integration with Emerson DeltaV system.
• Develop and maintain Supervisory Control and Data Acquisition (SCADA) systems, Trailblazer reporting systems, and equipment PLCs and interface hardware.
• Lead and support standalone system implementation and start-up, providing technical guidance on control panel/HMI layout and design, including power distribution, grounding, and I/O assignments.
• Collaborate with process subject matter experts (SMEs) to understand process requirements and translate them into automated solutions.
• Lead continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems.
• Collaborate with business partners to identify how standalone systems can improve workflow and productivity.
• Synthesize requirements from clients, customers, or end-users to develop automation solutions.
• Provide clear documentation for delivered solutions and processes, and support computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments according to Amgen and industry standards.
• Build business processes to support project scope in alignment with project timelines.
• Develop detailed specifications and engineering policies and procedures.
• Lead and support functional area projects for process equipment/utilities/facilities improvements and capital projects to integrate new drug substance manufacturing technologies.
• Lead and support technical root cause analysis, incident investigations, and troubleshooting on standalone systems.
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing configuration changes, and supporting qualification runs.
• Provide 24x7 Onsite/On Call Operational Support, Troubleshooting Support, Preventative and Corrective Maintenance, and Automation System spare parts management.
• Seek new and innovative ways to improve business operations, making them better and more cost-effective.

Benefits

• Competitive and comprehensive Total Rewards Plans aligned with local industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior