Senior Manufacturing Systems Engineer - PLC Systems

Amgen•Holly Springs, NC

3d•$136,907 - $185,227•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a biotechnology pioneer since 1980, has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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 not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company 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.
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.
Strong leadership, technical writing, and communication/presentation skills.

Nice To Haves

The ideal individual must be a 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.

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.