Manufacturing Specialist – Single Use Systems (SUS)

Role Summary

Manufacturing Specialist – Single Use Systems (SUS). The role is part of the Manufacturing Support team within the drug substance organization in Amgen North Carolina at Holly Springs, supporting SUS operations, new product introduction, new technology and equipment introduction, continuous improvement projects, CAPA ownership support, deviation trending, and optimization/implementation of single use technologies.

Responsibilities

• Support New Product introduction and projects through SUS mapping/drawing.
• Maintain and edit SUS Standard Operating Procedures (SOP).
• Support manufacturing and quality through the SUS defect/leak triage process ‚Äì perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings.
• Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation.
• Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
• Provide input for ANC representative to SUS network for improvements and troubleshooting.
• Support Vendor Change Notification assessments.
• Understand single-use material capabilities and user requirements for new technologies through interaction with end users.
• Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects (e.g., tubing management, material kitting and flow).

Qualifications

• Basic Qualifications:
  • High School/GED and 4 years of manufacturing or operations work experience OR
  • Associate‚Äôs Degree and 2 years of manufacturing or operations work experience OR
  • Bachelor‚Äôs Degree and 6 months of manufacturing or operations work experience OR
  • Master‚Äôs Degree
• Preferred Qualifications:
  • Experience with and understanding of Single-Use Systems.
  • Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
  • Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
  • Ability to communicate complex technical information with internal and external colleagues at varying levels in both presentation and technical writing forms.
  • Ability to coach, mentor and/or cross-train colleagues within core technical area.
  • Team player with ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
  • Ability to drive results through leadership of cross-functional teams.
  • Data analysis and/or data visualization skills.
  • Excellent writing skills; presentation experience to leadership.
  • Ability to navigate through ambiguity, determine tasks and timelines, and prioritize effectively.
  • Proficiency with computerized systems (e.g., Smartsheet, Excel, Trackwise, Veeva, Visio).
  • Experience translating business/user needs to user requirements and recommending solutions.
  • Experience in individually supporting key manufacturing systems with 24x7 operations.
  • Experience working in a fast-paced manufacturing environment; ability to adapt quickly to manufacturing operations demands.
  • Ability to collaborate with staff at all levels in manufacturing, process development, and quality.
  • Pro-active, result oriented, and ability to prioritize work to meet timelines.

Skills

• Single-Use Systems expertise
• GMP knowledge and technical writing
• Troubleshooting and investigation handling
• Project management and cross-functional collaboration
• Data analysis and visualization

Education

• High School/GED or higher (preferred degrees as listed in Basic Qualifications)

Additional Requirements

• Travel: Not specified
• Physical demands: Not specified