Manufacturing Specialist I – NPI & Process Improvement

Amgen; West Greenwich (RI); Hybrid; USD 108,000 - 146,000; Full time

Benefits offered by this job

Stock options

Health insurance

Retirement plan

Disability insurance

Job summary

Amgen is seeking a Specialist Mfg I to lead and support floor-level initiatives, partnering with Quality, Process Engineering and Regulatory teams. You will own quality records, help prioritize CAPA and deviations, and drive continuous improvement for manufacturing processes.

In this role, you will analyze data trends, manage documentation such as BOM updates, and support NPI programs from discovery to implementation, ensuring on-time delivery and compliance.

Qualifications

• Master’s degree (or foreign equivalent) in Engineering Management, Biology or a related field and 2 years of experience.
• Create and manage change control records in Veeva/CDOCs systems.
• Own change control records to support Manufacturing/NPI programs or other parallel projects.
• Create and update Manufacturing documents/revision of process BOM in Veeva/CDOCs; support Smartsheet Smart BOM project.
• Manage manufacturing document workflows in CDOCs/Veeva.
• Experience in CAPA, deviations and continuous improvement.
• Technical expertise on mechanical and automated functionality of systems including chromatography and DeltaV.

Responsibilities

• Lead and support planning and execution of key initiatives with cross functional teams on the production floor.
• Liaison with floor and cross-functional teams for NPI/PRI preparation and implementation.
• Provide data analyses to support management evaluation of process performance trends.
• Own and deliver on quality records and timelines (change control, CAPA, deviations).
• Support manufacturing organizations in prioritization to maximize plant performance and capacity.
• Collaborate with Quality, Process Engineering, Regulatory and Process Development to implement improvements.
• Facilitate cross-functional meetings for NPI programs.

Skills

Cross-functional collaboration

Data analysis

On-floor presence

Problem solving

Education

Master's degree in Engineering Management or Biology

Tools

Veeva/CDOCs

Smartsheet

DeltaV

PI Vision

Spotfire

Microsoft Teams

Job description

Amgen is seeking a Specialist Mfg I to lead and support floor-level initiatives, partnering with Quality, Process Engineering and Regulatory teams. You will own quality records, help prioritize CAPA and deviations, and drive continuous improvement for manufacturing processes.

In this role, you will analyze data trends, manage documentation such as BOM updates, and support NPI programs from discovery to implementation, ensuring on-time delivery and compliance.