Career CategoryManufacturing
Job DescriptionSenior Associate Manufacturing - Electronic Batch Record SupportWhat you will doLet's do this. Let's change the world. 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. During start up, Manufacturing Senior Associates will have oversight of electronic batch records operational readiness activities in multiple manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, and Column Packing. 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.
- 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.
- Assist in the implementation of new MES integrations and functionalities.
- Support manufacturing in the troubleshooting and execution of EBRs
- Create and maintain Electronic Batch Records
- Generation of paper process documents when required.
- Contribute to Lean Transformation through recording EBR metrics and application of continuous improvement tools.
- Participate and contribute to projects to introduce new products and/or advancement of new manufacturing technologies into the plant.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative team player with these qualifications.
Basic Qualifications:- 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
- Master's Degree
Preferred Qualifications:- 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 usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range86,048.05USD -116,417.95 USD
