Manufacturing Specialist I: NPI, CAPA & Process Improvement

BioSpace; West Greenwich (RI); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus program

Flexible work arrangements

Job summary

Amgen is seeking a Specialist Mfg I to lead planning and execution on the production floor, coordinating with Quality, Process Engineering, Regulatory and Process Development. You will manage change controls, BOMs, and manufacturing documents while driving continuous improvement and risk mitigation.

The role requires a Master’s degree with 2 years of related experience, and hands-on use of Veeva/CDOCs, Smartsheets, DeltaV, and CI tools to support NPI programs and plant performance.

Qualifications

• Master's degree in Engineering Management, Biology or related field with 2 years of related experience.
• Experience creating and managing change control records and manufacturing documents in Veeva/CDOCs.
• Familiarity with CAPA, deviations, and cross functional project delivery.

Responsibilities

• Lead and support planning and execution of key initiatives with cross functional teams at the production floor.
• Liaison at the floor and with cross function teams to assure program preparation, implementation, sustainment and lessons learned.
• Provide and analyze data to support management evaluation of process performance trends.
• Own quality records (change control, CAPA, deviations) and deliver to timelines.
• Support AR5/AR30 manufacturing organizations in prioritization and execution to maximize plant performance and capacity.
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements.
• Own and author critical SOPs and training documentation.
• Anticipate risk and build contingencies to mitigate impact.

Skills

Cross-functional collaboration

Data analysis

Problem solving

Quality mindset

Education

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

Tools

Veeva/CDOCs

CDOCs

Smartsheets

DeltaV

PI Vision

Spotfire

Job description

Amgen is seeking a Specialist Mfg I to lead planning and execution on the production floor, coordinating with Quality, Process Engineering, Regulatory and Process Development. You will manage change controls, BOMs, and manufacturing documents while driving continuous improvement and risk mitigation.

The role requires a Master’s degree with 2 years of related experience, and hands-on use of Veeva/CDOCs, Smartsheets, DeltaV, and CI tools to support NPI programs and plant performance.