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Senior Associate Manufacturing - Electronic Batch Record Support

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Amgen

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Location:
United States , Holly Springs

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

92002.00 - 108605.00 USD / Year
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Job Description:

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
  • Competitive benefits
  • Collaborative culture

Additional Information:

Job Posted:
January 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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