Amgen Inc

Senior Associate Manufacturing - Electronic Batch Record Support

US - North Carolina - Holly Springs · Senior

Sponsorship not specifiedDetected 12 hours ago

SAPPharmacy PracticeGMPCell CultureResearchCommunicationMicrosoft Office

About the role

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.
Our award-winning culture is collaborative, innovative, and science based.

Manufacturing support focused on Electronic Batch Record (EBR) generation using PAS-X (Korber), editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
Support manufacturing in the troubleshooting and execution of EBRs
Create and maintain Electronic Batch Records
In this vital role, you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility.
This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of EBR metrics and for communication between the operations teams and the various functional groups working through start-up activities.
Manufacturing Senior Associates can also support Standard Operating Procedure (SOP) creation, review, and approval; design of job aids and work instructions, advancement of digital tools to support manufacturing operations, and training of staff.

High School/GED and 4 years of manufacturing or operations work experience OR
Associate's Degree and 2 years of manufacturing or operations work experience OR
Bachelor's Degree and 6 months of manufacturing or operations work experience OR

Completion of NC BioWorks Certification Program.
Experience in biotechnology or pharmaceutical plant start up.
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
Excellent verbal and written communication (technical) skills.
Proficient Microsoft Office skills, and knowledge of other electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems.
Experience with PAS X (Korber) or comparable software for electronic batch records with some understanding of editing and validation.
What you can expect of us

We are all different, yet we all use our unique contributions to serve patients.

This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.