Senior Manufacturing Systems Engineer: Automation - DeltaV

Senior Manufacturing Systems Engineer:
Automation - Delta

V page is loaded## Senior Manufacturing Systems Engineer:
Automation - Delta Vremote type:
On Site locations:
US - North Carolina - Holly Springs time type:
Full time posted on:
Posted 8 Days Agojob requisition :
R-230818##
** 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  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:
Automation - Delta

V**##
** What you will do
** Let’s do this. Let’s change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant  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
** process automation systems
** to operate the new plant.##
** Site design, construction, start-up, and operational readiness
*** Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
* Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
* Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
* Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
* Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
* Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
* Support QA partners in performing computerized systems validation in a GxP environment
* Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards##
** Site Operations
*** Own and drive to completion Change Controls, CAPAs, and Deviations
* Lead and support technical root cause analysis, incident investigations, and troubleshooting
* Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
* Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
* Support day-to-day operations including rotational on-call support
* Perform and maintain Data Integrity Assessments…