Manufacturing Systems Engineer: Automation - PLC

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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. Manufacturing Systems Engineer: Automation - PLC What you will do Let’s do this. Let’s change the world. As a Manufacturing Systems Engineer, you will work with a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust automation systems to operate the new plant utility and standalone systems. This includes sophisticated and challenging system automation initiatives that require understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. Develop and maintain automation solutions using various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system. Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware. Support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including 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 from clients, customers, or end-users 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 the current Amgen and Industry standards. Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units. Ongoing operations: Support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility. 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, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable. Assist with Day-to-Day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Standalone Systems, Preventative and Corrective Maintenance, and Automation System spare parts management. Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively. What we expect of you! We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.

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

Nice To Haves

Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering.
Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation such as autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems, and 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 and 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 (e.g., cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
The ideal individual must be a self-directed great teammate ready to embrace a team-based culture that relies on collaboration for effective decision-making.
Strong technical writing and communication/presentation skills.

Responsibilities

Develop and maintain automation solutions using various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system.
Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware.
Support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including 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 from clients, customers, or end-users 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 the current Amgen and Industry standards.
Build the business processes to support the project scope in alignment with project timelines.
Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
Support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
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, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
Assist with Day-to-Day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Standalone Systems, Preventative and Corrective Maintenance, and Automation System spare parts management.
Be constantly curious and feed your passion and interests in groundbreaking technology.
Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.