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. This facility will combine disposable technologies with traditional stainless-steel equipment for maximum flexibility and will integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. This role is crucial for supporting the start-up of the Amgen North Carolina (ANC) manufacturing facility. The position involves generating electronic documentation, tracking EBR metrics, and facilitating communication between operations teams and functional groups during start-up activities. The Senior Associate will oversee electronic batch records operational readiness in various manufacturing areas, including Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, and Column Packing. Responsibilities also extend to supporting Standard Operating Procedure (SOP) creation, review, and approval, designing job aids and work instructions, 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
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.
- 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.
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.
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- 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
No Education Listed
