Specialist Manufacturing – Process Owner - Upstream / Downstream / Services
Amgen
August 18, 2026
On-site
Holly Springs, NC
Operations
Specialist Manufacturing – Process Owner (Upstream / Downstream / Services) – Multiple Positions
What You Will Do
- Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.
- Provide manufacturing floor support, troubleshooting, and hypercare during routine 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; identify opportunities for process optimization, operational improvement, and risk reduction.
- Support manufacturing change controls for process, equipment, procedural, and operational improvements.
- Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.
- Ensure processes are translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
- Provide technical input to manufacturing risk assessments; support identification and mitigation of risks.
- Participate in root cause analysis (RCA) for investigations, major deviations, and quality events.
- Support CAPA applicability, implementation, and effectiveness checks.
- Partner with Process Development, Supply Chain, Manufacturing, and Engineering for process overviews/knowledge transfer and material readiness/BOM alignment.
- Support MES and EBR activities; participate in inspection readiness/audits; escalate concerns.
Basic Qualifications
- Doctorate + 2 years biotechnology operations OR Master’s (Eng/biology/chem/biochem/related) + 4 years OR Bachelor’s + 6 years OR Associate’s + 10 years OR High school/GED + 12 years.
Preferred Qualifications
- Technical expertise in Upstream/Downstream/Manufacturing Services.
- Drug substance manufacturing process/equipment/unit operations knowledge.
- GMP operations experience; floor support/troubleshooting/hypercare.
- Operational readiness experience (water/dry runs, equipment testing, startup support).
- Experience authoring/maintaining GMP documentation (SOPs/procedures).
- Experience with manufacturing change controls.
- Risk assessments, RCAs, investigations, CAPA activities.
- MES and EBR experience in GMP environment.
- Single-use technologies and BOM structure knowledge.
- Strong technical writing, communication, problem-solving, and organizational skills.
What You Will Do
- Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.
- Provide manufacturing floor support, troubleshooting, and hypercare during routine 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; identify opportunities for process optimization, operational improvement, and risk reduction.
- Support manufacturing change controls for process, equipment, procedural, and operational improvements.
- Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.
- Ensure processes are translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
- Provide technical input to manufacturing risk assessments; support identification and mitigation of risks.
- Participate in root cause analysis (RCA) for investigations, major deviations, and quality events.
- Support CAPA applicability, implementation, and effectiveness checks.
- Partner with Process Development, Supply Chain, Manufacturing, and Engineering for process overviews/knowledge transfer and material readiness/BOM alignment.
- Support MES and EBR activities; participate in inspection readiness/audits; escalate concerns.
Basic Qualifications
- Doctorate + 2 years biotechnology operations OR Master’s (Eng/biology/chem/biochem/related) + 4 years OR Bachelor’s + 6 years OR Associate’s + 10 years OR High school/GED + 12 years.
Preferred Qualifications
- Technical expertise in Upstream/Downstream/Manufacturing Services.
- Drug substance manufacturing process/equipment/unit operations knowledge.
- GMP operations experience; floor support/troubleshooting/hypercare.
- Operational readiness experience (water/dry runs, equipment testing, startup support).
- Experience authoring/maintaining GMP documentation (SOPs/procedures).
- Experience with manufacturing change controls.
- Risk assessments, RCAs, investigations, CAPA activities.
- MES and EBR experience in GMP environment.
- Single-use technologies and BOM structure knowledge.
- Strong technical writing, communication, problem-solving, and organizational skills.