Manufacturing Systems Engineer Holly Springs, NC

Lets do this. Lets 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 DrugSubstancePlant Operations.

*The schedule for this position will be: Swing Shift 3pm - 11pm: Monday through Friday.*



In this vital roleas a member of the Facilities & Engineering (F&E) Automation teamyou will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant.



Responsibilities:

Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).

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.

Provide clear documentation for delivered solutions and processes.

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.

Support process automation systems 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.

Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.



Site Operations

Own and drive to completion Change Controls CAPAs and Deviations.

Support technical root cause analysis incident investigations and troubleshooting.

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.

Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

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.