Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm)

Role Summary

Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm) at Amgen, focused on managing and leading all aspects of a device assembly and packaging line, ensuring production operates in full cGMP compliance.

Responsibilities

• Lead manufacturing operations on the production floor, including equipment setup, operation, and troubleshooting.
• Maintain machine uptime, clear faults, and resolve stoppages on automated equipment.
• Ensure safety and compliance procedures are followed at all times.
• Escalate concerns to management when safety, equipment, supply, or quality are at risk.
• Provide training to manufacturing staff on processes and equipment.
• Provide troubleshooting and technical support for equipment, automation, and processes.
• Collaborate with Quality, Engineering, and Manufacturing Support to resolve manufacturing events promptly.
• Support Deviation Triage and CAPA processes.
• Write, review, and revise controlled documentation (SOPs, MPs, forms, technical reports, etc.).
• Apply process, scientific, operational, and compliance knowledge to support operations.
• Champion Lean Transformation and OE initiatives; drive continuous improvement.
• Participate in design, development, and implementation of processes for the manufacturing floor.
• Participate in commissioning, qualification, and validation of processes and equipment; resolve related issues.
• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development, and Regulatory Compliance in cross-functional teams.

Qualifications

• Basic Qualifications:
  • High school/GED + 4 years biotech/pharmaceutical manufacturing, process development, or quality experience
  • Or Associate’s + 2 years biotech/pharmaceutical manufacturing, process development, or quality experience
  • Or Bachelor’s + 6 months biotech/pharmaceutical manufacturing, process development, or quality experience
  • Or Master’s
• Preferred Qualifications:
  • Degree in Chemical Engineering, Industrial Engineering, or Life Sciences
  • Technical understanding of pharmaceutical/biotech packaging equipment and processes
  • Experience with cGMP
  • Ability to be flexible and manage change
  • Experience leading cross-functional teams
  • Experience managing multiple priorities in a fast-paced environment
  • Strong scientific and technical interactions with partner organizations (PD and F&E)
  • Experience in GMP Tech Support, GMP operations, process development, or scheduling
  • Experience with commissioning and qualification, NPI, cleaning validation, and PPQ
  • Ability to analyze and interpret technical data impacting operations
  • Background in lean manufacturing and operational excellence
  • Experience with manufacturing systems (MES, LIMS, Maximo, CCMS, SAP, etc.)

Skills

• Technical troubleshooting and problem-solving on manufacturing equipment
• Process documentation and SOP/MP writing and revision
• Cross-functional collaboration with Quality, Engineering, and Regulatory teams
• Lean and continuous improvement methodologies
• Adaptability to changing priorities and fast-paced environments

Education

• As listed in Qualifications: relevant degrees as specified in Preferred Qualifications

Additional Requirements

• Operational experience with device assembly & packaging lines and· cGMP compliance