Manufacturing Specialist-Process Engineer
Amgen
August 22, 2026
Remote friendly (New Albany, OH)
United States
Operations
Specialist, Manufacturing
Responsibilities:
- Execute manufacturing/quality systems including continuous improvement, technology transfer/NPI, process validation, manufacturing procedures, risk assessments, training, and non-conformance.
- Serve as primary production process owner for process support systems and support process ownership responsibilities.
- Initiate, revise, and approve manufacturing procedures reflecting current operations.
- Assess process performance (floor observation, performance data review) and provide troubleshooting.
- Evaluate, plan, and implement solutions for process improvement; support generation/provision of training materials.
- Conduct risk evaluations for new processes/changes and issue summary reports.
- Lead continuous improvement initiatives (cost/cycle time reduction) and support special projects.
- Support process monitoring parameters/control limits; collect data, assess deviations, and support quarterly reporting.
- Participate in technology transfer/NPI; assess documentation/materials/training/equipment modification needs.
- Assess, prioritize, justify, and support implementation/project management for process/equipment modifications.
- Triage non-conformance; assist investigations, corrective actions, and NC/CAPA closure; monitor/communicate incident trends; support root cause analysis trend evaluations.
- Assist with process validation protocols/reports and support collection/analysis of validation data.
- May participate in regulatory inspections.
- As manufacturing change owner, provide assessments on CCRB records impacting the process.
Basic Qualifications:
- Doctorate degree; or
- Master’s degree + 2 years in Engineering/Manufacturing/Packaging/Quality (pharma/medical device/biotech); or
- Bachelor’s degree + 4 years; or
- Associate’s degree + 8 years; or
- High school diploma/GED + 10 years.
Preferred Qualifications:
- Bio-processing/manufacturing operations expertise; process improvement implementation.
- Lean (Kaizen, Six Sigma, Operational Excellence) and problem-solving.
- Cross-functional leadership experience.
- Change control/change management experience.
- GMP production operations experience.
- Regulatory knowledge/interactions.
- Project management; strong technical writing/presentation/verbal skills.
- Data analysis/control charting.
Application instructions:
- Apply now via careers.amgen.com.
Responsibilities:
- Execute manufacturing/quality systems including continuous improvement, technology transfer/NPI, process validation, manufacturing procedures, risk assessments, training, and non-conformance.
- Serve as primary production process owner for process support systems and support process ownership responsibilities.
- Initiate, revise, and approve manufacturing procedures reflecting current operations.
- Assess process performance (floor observation, performance data review) and provide troubleshooting.
- Evaluate, plan, and implement solutions for process improvement; support generation/provision of training materials.
- Conduct risk evaluations for new processes/changes and issue summary reports.
- Lead continuous improvement initiatives (cost/cycle time reduction) and support special projects.
- Support process monitoring parameters/control limits; collect data, assess deviations, and support quarterly reporting.
- Participate in technology transfer/NPI; assess documentation/materials/training/equipment modification needs.
- Assess, prioritize, justify, and support implementation/project management for process/equipment modifications.
- Triage non-conformance; assist investigations, corrective actions, and NC/CAPA closure; monitor/communicate incident trends; support root cause analysis trend evaluations.
- Assist with process validation protocols/reports and support collection/analysis of validation data.
- May participate in regulatory inspections.
- As manufacturing change owner, provide assessments on CCRB records impacting the process.
Basic Qualifications:
- Doctorate degree; or
- Master’s degree + 2 years in Engineering/Manufacturing/Packaging/Quality (pharma/medical device/biotech); or
- Bachelor’s degree + 4 years; or
- Associate’s degree + 8 years; or
- High school diploma/GED + 10 years.
Preferred Qualifications:
- Bio-processing/manufacturing operations expertise; process improvement implementation.
- Lean (Kaizen, Six Sigma, Operational Excellence) and problem-solving.
- Cross-functional leadership experience.
- Change control/change management experience.
- GMP production operations experience.
- Regulatory knowledge/interactions.
- Project management; strong technical writing/presentation/verbal skills.
- Data analysis/control charting.
Application instructions:
- Apply now via careers.amgen.com.