Remote Manufacturing Specialist I: Process & Quality

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

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life insurance

Disability insurance

Annual bonus

Flexible work model

Job summary

Amgen is seeking a Specialist Mfg I to lead and support planning and execution of key initiatives on the production floor, coordinating across Quality, Process Engineering, Regulatory and Process Development. You will own quality records and help maximize plant performance and capacity through continuous improvement.

The role requires a Master’s degree in Engineering Management, Biology, or related field with relevant experience, plus hands-on expertise in change control and manufacturing

Qualifications

• Master’s degree in Engineering Management, Biology or related field with 2 years of related experience.
• Experience creating and managing change control records in Veeva/CDOCs.
• Knowledge of DeltaV, PI Vision and Spotfire for troubleshooting.

Responsibilities

• Lead and support planning and execution of key initiatives with cross functional teams on the production floor.
• Liaise on the floor and with cross function teams to assure program preparation and sustainment; share lessons learned.
• Own quality records (change control, CAPA, deviations) and ensure timely delivery.
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements.

Skills

Cross-functional collaboration

Data analysis

Problem solving

Clear communication

Education

Master’s degree in Engineering Management, Biology or related field

Tools

Veeva/CDOCs

Smartsheet

DeltaV

PI Vision

Spotfire

Job description

Amgen is seeking a Specialist Mfg I to lead and support planning and execution of key initiatives on the production floor, coordinating across Quality, Process Engineering, Regulatory and Process Development. You will own quality records and help maximize plant performance and capacity through continuous improvement.

The role requires a Master’s degree in Engineering Management, Biology, or related field with relevant experience, plus hands-on expertise in change control and manufacturing