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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.
Job Responsibility
Managing and leading all aspects of a device assembly & packaging line
Maintaining production in full cGMP compliance
Assisting with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed
Leading manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting
Maintaining machine uptime, perform any fault clearing and clear stoppages on automated equipment
Ensuring all safety and compliance procedures are followed at all times
Raising appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk
Providing training to manufacturing staff on process and equipment
Providing troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor
Collaborating with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner
Supporting Deviation Triage and Corrective and Preventive Actions (CAPA) processes
Applying process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations
Championing Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant
Participating in the design, development, and implementation of processes in support of the manufacturing floor
Participating in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation
Collaborating with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams
Requirements
High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
Or Associate’s + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
Or Bachelor’s + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
Or Master's
Nice to have
Degree in Chemical Engineering, Industrial Engineering or Life Sciences
Technical understanding of pharmaceutical/biotech packaging equipment and processes
Experience with Current Good Manufacturing Practices (cGMP)
Ability to be flexible and manage change
Experience participating in and leading cross-functional teams
What we offer
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan