Director Engineering

Role: Director of Engineering overseeing engineering and maintenance for Amgen’s GMP-compliant assembly and packaging operations. Main objectives include ensuring safety, regulatory compliance, equipment reliability, and process improvements in a highly regulated biologics manufacturing environment. Responsibilities encompass leading safety programs, managing teams, optimizing plant capacity, supporting capital projects, and ensuring audit readiness. The role involves cross-functional collaboration with plant operations, Facilities & Engineering, Quality, and Regulatory teams.

Qualifications: Advanced degree (Doctorate, Master’s, or Bachelor’s) with 4+ years’ experience in pharma, biotech, or medical device manufacturing, plus at least 4 years of leadership experience managing teams, projects, or resources. Preferred experience includes 8+ years in operations, 10+ years in regulated environments (FDA/cGMP), and prior leadership of engineering in a GMP setting. Demonstrated expertise in manufacturing equipment, regulatory trends, and team development are essential.

High-Value Details: Focus on biologics or biotech manufacturing, GMP compliance, and regulated biotech environment experience. Leadership in engineering, troubleshooting, and continuous process improvement in a dynamic, high-demand setting are key. The role involves interfacing with diverse technical and operational stakeholders.

Work Setup: Not specified, but likely on-site given plant oversight and GMP requirements, with potential for cross-site collaboration.