GMP Packaging Operations Lead - Two Shifts

Cintrifuse; Cincinnati (OH); On-site; USD 70,000 - 110,000; Full time

Job summary

Cintrifuse is seeking an experienced packaging operations leader for onsite, full-time work in Cincinnati. The role requires directing two shifts, aligning staffing with production plans and ensuring strict compliance with GMP and FDA requirements.

You will drive continuous improvement and manage documentation, training and quality controls. Ideal candidates have 5+ years in regulated packaging, strong leadership, and ERP experience, with a track record of achieving safety, quality and

Qualifications

• High school diploma or GED.
• Ability to read, write and communicate effectively in English.
• Minimum five (5) years of production experience in a regulated manufacturing or cleanroom environment, including relevant packaging operations experience.
• Demonstrated experience managing production schedules, quality documentation, employee performance and operational metrics.
• Prior leadership experience in FDA-regulated medical device or pharmaceutical packaging operations and applicable GMP requirements.
• Prior leadership experience directly managing teams across two shifts, including shift leads or frontline supervisors.
• Experience with automated packaging equipment, process validation, SAP or comparable ERP systems, and lean daily management.
• Preferred: experience with medical device or pharma manufacturing; minimum three years leadership for 10+ employees; Bachelor’s degree in related field.

Responsibilities

• Lead packaging operations across two production shifts to meet safety, quality, delivery, productivity and cost objectives.
• Own execution against daily and weekly packaging output targets, labor productivity, schedule attainment, scrap and downtime.
• Provide visible floor leadership with daily management processes and shift handoffs.
• Ensure packaging activities comply with GMP, FDA requirements and quality-system controls.
• Verify timely completion and review of production records, packaging documentation and reconciliations.
• Identify deviations and support investigations and CAPA implementations.
• Coordinate with Maintenance and Engineering on equipment setup, preventive maintenance and improvements.
• Coordinate with Planning, Warehouse and Supply Chain for packaging material availability and inventory transactions.
• Oversee staffing plans, scheduling, training and qualification across both shifts.
• Coach and develop technicians and team leads with performance feedback and evaluations.
• Partner with Quality and Training for audits and training compliance.
• Champion continuous improvement using root-cause problem solving and lean daily management.
• Maintain SAP/ERP transactions and administrative records.
• Escalate operational risks and capacity constraints to Manufacturing leadership.
• Collaborate with upstream and downstream teams for timely product flow.
• Perform other duties as assigned.

Skills

Leadership

Packaging operations

Schedule management

GMP FDA compliance

Lean daily management

Cross-shift leadership

SAP experience

Data-driven performance

Education

High school diploma or GED

Bachelor’s degree in Business, Engineering, Operations Management or related

Tools

SAP

ERP systems

Microsoft Office

Timekeeping systems

Job description

Cintrifuse is seeking an experienced packaging operations leader for onsite, full-time work in Cincinnati. The role requires directing two shifts, aligning staffing with production plans and ensuring strict compliance with GMP and FDA requirements.

You will drive continuous improvement and manage documentation, training and quality controls. Ideal candidates have 5+ years in regulated packaging, strong leadership, and ERP experience, with a track record of achieving safety, quality and