Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)
About The Position
Amgen is seeking a Senior Associate Manufacturing - Electronic Batch Record Support to join their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility, in North Carolina. This facility combines disposable technologies with traditional stainless-steel equipment for flexible operations and integrates Industry 4.0 capabilities and sustainability innovations. The role is crucial for supporting the start-up of this new facility, focusing on electronic documentation, tracking EBR metrics, and facilitating communication between operations and functional groups during start-up activities. The position involves overseeing electronic batch record operational readiness in various manufacturing areas, supporting SOP creation and review, designing job aids, advancing digital tools, and training 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 Master’s Degree
- 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.
Nice To Haves
- 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.
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.
- 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.
- Support optimization of EBRs to improve functionality and align with process requirements.
- 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.
- 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.
- 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.
Benefits
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
