Senior Associate Manufacturing I - New Albany, OH

Manufacturing Senior Associate

In this role you will be managing and leading all aspects of a device assembly & packaging line. Responsibility includes maintaining production in full cGMP compliance. Assist with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed.

Lead manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting.

Maintain machine uptime, perform any fault clearing and clear stoppages on automated equipment.

Ensure all safety and compliance procedures are followed at all times.

Raise appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.

Provide training to manufacturing staff on process and equipment.

Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.

Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner.

Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes.

Write, review & revise controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc)

Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.

Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant.

Participate in the design, development, and implementation of processes in support of the manufacturing floor.

Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation.

Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.