Senior Manufacturing Associate – Single Use Systems (SUS)

• 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 – 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. For example, improvements around tubing management, material kitting and flow

• 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
• 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 successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical area
• Team player - 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 – presentation to leadership
• Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively
• Proficiency in computerized systems for example, Smartsheet, excel, Trackwise, Veeva, Visio
• Expertise with translating business/user needs to user requirements and recommend solutions
• Experience in individually supporting key manufacturing systems with 24x7 operations
• The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality
• Pro-active, result oriented, and ability to prioritize work to meet timelines

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards