Senior Packaging Supervisor

Cintrifuse; Cincinnati (OH); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Packaging operations

Schedule management

GMP FDA compliance

Lean daily management

Cross-shift leadership

SAP experience

Data-driven performance

Educación

High school diploma or GED

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

Herramientas

SAP

ERP systems

Microsoft Office

Timekeeping systems

Descripción del empleo

Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required

• 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 manufacturing or pharma manufacturing
• Minimum three (3) years of progressive manufacturing leadership experience, including responsibility for teams of 10 or more employees and demonstrated ability to coordinate operations across multiple shifts.
• Bachelor’s degree in Business, Engineering, Operations Management or related discipline.

Skills & Competencies

• Strong floor leadership, coaching and employee development skills; ability to set clear expectations and hold teams accountable.
• Ability to prioritize multiple production demands, resolve escalations and remain composed under pressure.
• Strong understanding of packaging process controls, line clearance, labeling, traceability, reconciliation and documentation accuracy.
• Ability to identify and troubleshoot equipment, process and material issues in partnership with technical support functions.
• Data-driven approach to output, units per person per day (UPD), labor efficiency, scrap, downtime and schedule attainment.
• Clear, consistent communication between both shifts and with Quality, Engineering, Maintenance, Planning and Supply Chain.
• Proficiency with Microsoft Office, ERP and timekeeping systems.

Physical Requirements

• Ability to work in manufacturing and controlled environments while wearing required PPE for extended periods.
• Ability to stand or remain stationary for extended periods, walk production areas and perform visual inspections.
• Fine motor dexterity and ability to identify small product or packaging defects, with or without magnification as required.
• Ability to move up to 25 pounds as needed.

RESPONSIBILITIES

• Lead packaging operations across two production shifts to meet established safety, quality, delivery, productivity and cost objectives; translate the production plan into aligned staffing, equipment and material priorities for each shift.
• Own execution against daily and weekly packaging output targets, labor productivity (including UPD), schedule attainment, scrap and downtime; identify performance gaps and implement timely corrective actions.
• Provide visible floor leadership across both shifts and establish structured daily management, including shift start-up reviews, performance boards, escalation routines, standardized shift handoffs and follow-up on issues carried between shifts.
• Ensure packaging activities comply with approved procedures, GMP, FDA requirements and applicable quality-system controls.
• Verify timely and accurate completion and real-time review of production records, packaging documentation, label controls, line clearances and component/finished-goods reconciliations.
• Immediately identify, contain and escalation deviations, nonconforming product, documentation discrepancies and potential product-quality issues; support investigations and CAPA implementation.
• Ensure equipment is cleaned, maintained, properly set up and released for use under applicable procedures; partner with Maintenance and Engineering on troubleshooting, preventive maintenance and equipment improvements.
• Coordinate with Planning, Warehouse and Supply Chain to confirm packaging material availability, accurate inventory transactions, traceability and disposition of scrap or unused components.
• Own staffing plans, employee scheduling, attendance management, hiring, onboarding, training and qualification across both shifts; ensure appropriate leadership presence and certified coverage of critical packaging processes on each shift.
• Coach and develop manufacturing assembly technicians, team leads and other assigned personnel across both shifts; set consistent expectations, provide frequent performance feedback, formal evaluations and corrective counseling when appropriate.
• Partner with Quality and Training to maintain training compliance, procedural adherence and readiness for internal, customer and regulatory audits.
• Champion continuous improvement using root-cause problem solving, standard work, waste reduction, changeover improvement and lean daily management.
• Initiate or support controlled document revisions, change controls, nonconformances and corrective/preventive actions related to packaging operations.
• Maintain accurate SAP/ERP production, inventory, scrap and labor transactions and ensure timely completion of required administrative records.
• Proactively elevate operational risks, capacity constraints, quality concerns and recovery plans to Manufacturing leadership, with clear accountability for follow-through across both shifts.
• Coordinate effectively with upstream manufacturing and downstream warehouse/distribution activities to ensure timely, compliant product flow.
• Perform other duties as assigned consistent with the needs of the business.