Manufacturing Senior Associate - Single Use Systems (SUS)

Amgen; Holly Springs (NC); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Amgen North Carolina in Holly Springs is seeking a Manufacturing Senior Associate - Single Use Systems (SUS) to join the Manufacturing Support team. You will support new product introductions, SUS technology deployment, and continuous improvement projects in a high‑yield drug substance environment.

Key tasks include SUS mapping, maintaining SOPs, leading troubleshooting, and contributing to CAPA and deviation handling.

Qualifications

• Eight years of Engineering or Operations experience (or equivalent) with related GMP manufacturing exposure.
• Experience with single-use systems (SUS) and drug substance processing.
• Ability to communicate complex technical information clearly in writing and presentations.

Responsabilités

• Support New Product introduction and SUS mapping/drawing.
• Maintain and edit SUS SOPs.
• Support manufacturing and quality through SUS defect/leak triage process.
• Initiate EN/SICAR records and coordinate investigations with vendors.
• Maintain up-to-date EN/SICAR/EE trackers and manage small to medium projects.
• Collaborate with CI leads to drive SUS improvement projects.

Connaissances

Data analysis

Team collaboration

Technical writing

Problem solving

Formation

High School diploma / GED

Associate's degree

Bachelor's degree

Master's degree

Outils

Smartsheet

Excel

Trackwise

Veeva

Visio

Lucidchart

Description du poste

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

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 Senior Associate - Single Use Systems (SUS)

Live

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.

Key responsibilities include:

• 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.

Win

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:

Basic Qualifications:

• High School diploma / GED and 8 years of Engineering or Operations experience
• OR
• Associate's degree and 6 years of Engineering or Operations experience
• OR
• Bachelor's degree and 2 years of Engineering or Operations experience
• OR
• Master's 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 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 to leadership.
• Determines work tasks and timelines self-sufficiently - ability to navigate through ambiguity and prioritize effective
• Experience in computerized systems for example, Smartsheet, Excel, Trackwise, Veeva, Visio, Lucid Chart.
• 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,