Senior Manufacturing Systems Engineer – DeltaV Batch

Amgen•Holly Springs, NC

3d•$136,907 - $185,227•Onsite

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. Senior Manufacturing Systems Engineer – DeltaV Batch What you will do In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, and drive innovation and support manufacturing’s upstream, downstream, and solution preparation automation needs. You will solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations. You will partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start-up, focusing on 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 Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.
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 with upstream/downstream/solution prep unit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/diafiltration among others.
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 primarily utilizing Emerson DeltaV Distributed Control System (DCS) for upstream, downstream, and/or solution prep operations.
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 Upstream, Downstream, and/or Solution prep Automation processes.
Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, and Automation System spare parts management
Lead and support functional area projects focused on improving process 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.