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Be 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.
Job Responsibility:
Support the start-up of the Amgen North Carolina (ANC) manufacturing facility
Generation of electronic documentation
Tracking of EBR metrics
Communication between the operations teams and the various functional groups
Oversight of electronic batch records operational readiness activities in multiple manufacturing areas
Support Standard Operating Procedure (SOP) creation, review, and approval
Design of job aids and work instructions
Advancement of digital tools to support manufacturing operations
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
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
Requirements:
High School/GED and 4 years of manufacturing or operations work experience
Associate’s Degree and 2 years of manufacturing or operations work experience
Bachelor’s Degree and 6 months of manufacturing or operations work experience
Master’s Degree
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 we offer:
Competitive and comprehensive Total Rewards Plans
Support for professional and personal growth and well-being