Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm)

Role Summary

Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm) on a device assembly and packaging line, leading production in full cGMP compliance and supervising technicians to ensure 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.
• Escalate appropriate concerns to management when safety, equipment functionality, product supply, or quality are at risk.
• Provide training to manufacturing staff on process and equipment.
• Provide troubleshooting 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 CAPA processes.
• Write, review & revise controlled documentation (SOPs, 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 to drive continuous improvement in the plant.
• Participate in the design, development, and implementation of processes on the manufacturing floor.
• Participate in the development, implementation, and issue resolution of process equipment Commissioning, Qualification and Validation.
• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.

Qualifications

• Basic Qualifications: High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience; or Associate‚Äôs + 2 years; or Bachelor‚Äôs + 6 months; or Master‚Äôs.
• Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering or Life Sciences; technical understanding of pharmaceutical/biotech packaging equipment and processes; experience with cGMP; ability to be flexible and manage change; experience leading cross-functional teams; ability to manage multiple priorities in a fast-paced environment; strong scientific/technical interactions with partner organizations; experience in GMP tech support, GMP operations, process development or scheduling; experience with commissioning and qualification, NPI, cleaning validation, and PPK; ability to analyze technical data; background in lean manufacturing and operational excellence; expertise in MES, LIMS, Maximo, CCMS, SAP, etc.

Skills

• Technical troubleshooting and device assembly/packaging line operations
• Process documentation and SOP/MP writing
• Cross-functional collaboration and training delivery
• Lean manufacturing and continuous improvement
• Data interpretation and performance metrics

Education

• Relevant degree or equivalent experience as listed in qualifications

Additional Requirements

• None beyond listed qualifications and responsibilities.