Manufacturing Systems Engineer: BAS/QBAS

Amgen

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: BAS/QBAS 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. This includes sophisticated and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.

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 BAS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.
Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC, and field device/instrumentation technologies.
Experience with Siemens Building Automation Desigo CC system, Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities with Amgen DTI, 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 implementation.
Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.)
The ideal individual must be a self-directed team player ready to embrace a team-based culture that relies on collaboration for effective decision-making.
Strong technical writing and communication/presentation skills.

Responsibilities

Maintain the Building Automation System (BAS/QBAS) on Siemens Desigo CC.
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
Collaborate with business partners to understand how utility and building equipment systems automation 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.
Maintain detailed specification and engineering policies and procedures that affect multiple organizational units.
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
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 utilities and building automation controls.
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 Plant and Mfg. Operations, Utility systems, Utility and BAS Administration, 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.