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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.
Job Responsibility
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 Systems 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
On-site and up to 10% domestic/international travel
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
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
Strong leadership, technical writing, and communication/presentation skills
Nice to have
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
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
Strong leadership, technical writing, and communication/presentation skills