Specialist Manufacturing – Process Owner - Upstream / Downstream / Services

About this role

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION?  

You’ve   worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience ,   and passion to work toward your goals? 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, reaching over   10 million patients   worldwide. Come do your best   work   alongside other innovative, driven professionals in this meaningful role.  

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 disposable 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.  

Specialist Manufacturing – Process Owner  - Upstream / Downstream / Services (Multiple Positions)

Live  

What You Will Do  

In this vital role, you will serve as a Process Owner within the Manufacturing Support organization at   Amgen   North Carolina (ANC). The Process Owner serves as a technical process steward and key interface between Manufacturing Operations and support organizations. This role   is responsible for   supporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initi atives.  

This position may support one of the following manufacturing areas depending on business needs and organizational assignment: Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).  

• Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.  

• Provide manufacturing floor support, troubleshooting   assistance , and   hypercare   during routine manufacturing operations, process changes, startup activities, and first-time executions.  

• Support operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing   support .  

• Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.  

• Monitor process performance and   identify   opportunities for process optimization, operational improvement, and risk reduction.  

• Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.  

• Author, revise, review, and   maintain   manufacturing SOPs, forms, and other GMP documentation.  

• Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.  

• Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.  

• Participate in root cause analysis (RCA) activities and provide technical process   expertise   to support manufacturing investigations, major deviations, and quality events.  

• Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.  

• Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.  

• Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and Bill of Material (BOM) alignment, including single-use assemblies and consumables.  

• Support MES and EBR activities by providing process   expertise   and manufacturing representation.  

• Participate in   inspection   readiness activities and support audits as   required .  

• Appropriately escalate process, operational, quality, and compliance concerns.  

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Win  

What We Expect of You  

Basic Qualifications  

• Doctorate degree and 2 years of biotechnology operations experience OR

• Master's degree in Engineering , Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR  

• Bachelor's degree and 6 years of biotechnology operations experience OR  

• Associate's degree and 10 years of biotechnology operations experience OR  

• High school diploma / GED and 12 years of biotechnology operations experience  

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Preferred Qualifications  

• Technical   expertise   in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).  

• Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations.  

• Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.  

• Experience supporting manufacturing floor operations, troubleshooting, and   hypercare   activities.  

• Experience supporting operational readiness activities including water runs, dry runs, equipment testing, and startup support.  

• Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures.  

• Experience supporting manufacturing change controls and implementation activities.  

• Experience   participating   in risk assessments, root cause analyses, investigations, and CAPA implementation activities.  

• Experience supporting CAPA applicability assessments and effectiveness checks.  

• Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment.  

• Knowledge of single-use technologies and Bill of Material (BOM

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