Manufacturing Specialist — Lean, Six Sigma & Process Improvement

BioSpace; West Greenwich (RI); On-site; USD 113,000 - 146,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental and vision coverage

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen seeks a Specialist Manufacturing I to lead and support production floor initiatives, ensuring program readiness and sustained performance. You will analyze data to drive management decisions, own quality records, and coordinate with Quality, Process Engineering, Regulatory, and Process Development to implement improvements.

The role requires a Master’s degree in a related field and 2 years of manufacturing experience, with emphasis on Lean, Six Sigma, GMP, and cross‑functional teamwork.

Qualifications

• Masters degree in Regulatory Affairs and Quality Assurance, Bioengineering, Chemical Engineering or related field.
• 2 years of experience in a manufacturing‑related occupation.
• Experience applying Lean manufacturing and Six Sigma to optimize processes.
• Familiarity with GMP production operations and quality systems.

Responsibilities

• Lead and support planning and execution of key initiatives on the production floor.
• Coordinate with cross functional teams to prep and sustain programs (NPI/PRI).
• Own quality records including change control, CAPA, deviations, and timely deliverables.
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to drive improvements.
• Support frontline managers on the floor and author SOPs and training materials.

Skills

Lean manufacturing

Six Sigma

5S/Problem solving

GMP operations

Project management

Data analysis

Cross-functional collaboration

Education

Master’s degree in Regulatory Affairs and Quality Assurance, Bioengineering, Chemical Engineering or related field

Tools

Spotfire

MES (PAS-X)

PI System

TrackWise

Veeva

SAP (ERP)

Job description

Amgen seeks a Specialist Manufacturing I to lead and support production floor initiatives, ensuring program readiness and sustained performance. You will analyze data to drive management decisions, own quality records, and coordinate with Quality, Process Engineering, Regulatory, and Process Development to implement improvements.

The role requires a Master’s degree in a related field and 2 years of manufacturing experience, with emphasis on Lean, Six Sigma, GMP, and cross‑functional teamwork.