Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)

Role: Senior Associate supporting electronic batch record (EBR) activities during the startup of Amgen's new manufacturing facility, focusing on digital documentation, process validation, and MES system integration. Responsibilities include generating, editing, troubleshooting, and validating EBRs using PAS-X, supporting process optimization, SOP creation, and digital tool implementation across multiple manufacturing areas such as upstream, downstream, and analytical testing. Requirements: High School/GED with 4+ years, Associate's with 2+ years, Bachelor's with 6 months, or Master's degree in a relevant field; experience in biotech/pharma manufacturing or plant startup preferred. Skills: familiarity with cGMP, MES systems, electronic documentation, process troubleshooting, and digital tools like SAP and Delta V; PAS-X experience advantageous. High-Value: biotechnology manufacturing startup, focus on biologics, process validation, digital systems, and compliance in a regulated environment. Collaboration with operations and quality teams during plant start-up, with potential remote work options.