Specialist Manufacturing Process Owner - Upstream / Downstream / Services

Amgen SA; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen is hiring for Specialist Manufacturing – Process Owner in Holly Springs, NC. The role spans Upstream, Downstream and Services with a focus on ownership of manufacturing processes, equipment, and unit operations.

You will provide floor support, troubleshoot issues, and assist with startup and first-time executions. The candidate should hold advanced biotech degrees with extensive GMP experience and strong technical writing skills.

Qualifications

• Advanced degree with biotech operations experience.
• Experience in GMP pharmaceutical manufacturing.
• Ability to write and maintain GMP docs.

Responsibilities

• Serve as technical process owner for assigned manufacturing processes and equipment.
• Provide floor support, troubleshooting, and hypercare during operations.
• Support readiness activities including water/dry runs and EBR testing.
• Collaborate with operations to ensure compliant, efficient execution.
• Identify process optimization opportunities and risk reductions.
• Participate in change controls and CAPA activities.
• Translate processes into SOPs and workflows; support training material creation.
• Assist in RCA investigations and quality events; support audits.

Skills

GMP knowledge

Troubleshooting

Process ownership

Documentation

Education

Doctorate in Biotech/related

Master's in Engineering/Biology/chemistry

Bachelor's in Biotech

Associate's in biotech ops

High school + 12 yrs biotech ops

Tools

MES

EBR

SOP authoring

Job description

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

How we might 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.

What You Will Do

• 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 escalated process, operational, quality, and compliance concerns.

What We Expect of You

Basic Qualifications

• Doctorate degree and 2 years of biotechnology operations experience

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

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

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

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

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.

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.