Manufacturing Senior Associate 3rd Shift (10:30pm-7am)

Role Summary

Manufacturing Senior Associate on the 3rd shift (10:30 pm – 7:00 am) responsible for managing and leading all aspects of a device assembly and packaging line, maintaining production in full cGMP compliance, supervising and developing technicians, and ensuring production schedules are completed.

Responsibilities

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

Qualifications

• Required: High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
• Required: Associate’s + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
• Required: Bachelor’s + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
• Required: Master’s
• Preferred: Degree in Chemical Engineering, Industrial Engineering or Life Sciences
• Preferred: Technical understanding of pharmaceutical/biotech packaging equipment and processes
• Preferred: Experience with Current Good Manufacturing Practices (cGMP)
• Preferred: Ability to be flexible and manage change
• Preferred: Experience participating in and leading cross-functional teams

Education

• High school diploma or GED plus 4 years biotech or pharmaceutical manufacturing, process development or quality experience
• Associate’s degree plus 2 years biotech or pharmaceutical manufacturing, process development or quality experience
• Bachelor’s degree plus 6 months biotech or pharmaceutical manufacturing, process development or quality experience
• Master’s degree