Amgen
Senior Associate Manufacturing - Electronic Batch Record Support
US - North Carolina - Holly Springs · Senior
Sponsorship not specifiedDetected 5 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.
Responsibilities
- 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.
Requirements
- 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
Nice to have
- 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
Compensation
- 86,048.05USD -116,417.95 USD
Company info
- We are all different, yet we all use our unique contributions to serve patients.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.