Specialist Manufacturing – Process Owner - Upstream / Downstream / Services

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 initiatives. 

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) structures. 

• Strong technical writing, communication, problem-solving, and organizational skills. 

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Thrive 

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being through comprehensive benefits, career development opportunities, and a collaborative culture.