Senior Manufacturing Systems Engineer - PLC Systems

Amgen•Holly Springs, NC

1d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotech, 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 stainless steel equipment and integrates industry 4.0 capabilities and sustainability innovations. The Senior Manufacturing Systems Engineer - PLC will be a vital role within the Facilities & Engineering (F&E) group, leading technical projects, driving innovation, and supporting PLC-based processes and utility skid equipment automation. The position involves solving complex engineering problems, ensuring alignment with strategic objectives, and providing leadership to the Automation Engineering team supporting 24/7 manufacturing operations. The role will partner with the capital project team for design, build, commissioning, and qualification of new equipment and systems, developing domain expertise in manufacturing automation.

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.
Extensive experience with process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies such as Rockwell platforms.
Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.
Experience in programming, design, installation and lifecycle management of PLC and field device/instrumentation technologies.
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.
Self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
Strong leadership, technical writing, and communication/presentation skills.

Responsibilities

Site design, construction, start-up, and operational readiness: Provide support to the capital project team with a strong focus on safety and on-time facility start- up.
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions for PLC based systems.
Work with platform leads to ensure standalone PLC based systems are designed with the proper network connectivity and system- to- system communication to enable centralized monitoring and alarming.
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls.
Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units.
Provide mentoring to develop and accelerate site technical automation capabilities.
Act as system owner for standalone PLC based systems.
Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, preventive and corrective maintenance, system administration, and Automation System spare parts management.
Lead and support functional area projects focused on improving equipment/utilities/facilities as well as capital projects to integrate new drug substance manufacturing technologies into the facility.
Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
Prepare and review Standard Operating Procedures (SOP) and cGMP documents.