Manufacturing Specialist – Single Use Systems (SUS)

Amgen•Holly Springs, NC

14d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manufacturing Specialist – Single Use Systems (SUS) What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction, new technology and equipment introduction, continuous improvement projects, supporting CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance organization in Amgen North Carolina at Holly Springs. This role is critical for Amgen North Carolina’s success and key in supporting single-use (SUS) operations. 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems, with the following qualifications.

Requirements

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

Nice To Haves

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.

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 – 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.