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Senior Manufacturing Systems Engineer – DeltaV

Amgen

Holly Springs, NC, USonsite

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About this role

Career Category Engineering Job Description 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  

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.  

Job responsibilities include:  

• 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.   

• Site Operations:  

• 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.  

• On-site role   and u p to 10% domestic/international travel   

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.  

Basic Qualifications:    • 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

Preferred Qualifications:  

• 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.  

• Extensi

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