Senior Device Manufacturing Lead - cGMP

BioSpace; New Albany (OH); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision

Stock-based incentives

Flexible work models

Career development opportunities

Job summary

Amgen in New Albany, OH, is seeking a Manufacturing Senior Associate to manage a device assembly & packaging line in a cgmp environment. You will supervise technicians, support equipment setup, and safeguard uptime and safety on the floor.

Responsibilities include writing SOPs, CAPA support, and collaborating with Quality, Engineering and Mfg to resolve issues while driving continuous improvement and Lean initiatives.

Qualifications

• Bachelor's degree in Chemical Engineering, Industrial Engineering or Life Sciences.
• 4+ years biotech/pharma manufacturing experience preferred.
• Experience with cGMP and process development or quality functions.

Responsibilities

• Lead manufacturing operations on a production line ensuring cgmp compliance.
• Supervise technicians and maintain machine uptime and safety.
• Write, review and revise SOPs and CAPA-related documentation.

Skills

Lean manufacturing

GMP knowledge

Cross-functional teamwork

Troubleshooting

Documentation and SOPs

Education

Bachelor's degree in Chemical Engineering, Industrial Engineering or Life Sciences

Master's (preferred)

Tools

MES

LIMS

Maximo

CCMS

SAP

Job description

Amgen in New Albany, OH, is seeking a Manufacturing Senior Associate to manage a device assembly & packaging line in a cgmp environment. You will supervise technicians, support equipment setup, and safeguard uptime and safety on the floor.

Responsibilities include writing SOPs, CAPA support, and collaborating with Quality, Engineering and Mfg to resolve issues while driving continuous improvement and Lean initiatives.