Senior Packaging Supervisor

Enable Injections, Inc.; Cincinnati (OH); Presencial; USD 90.000 - 125.000; Jornada completa

Descripción de la vacante

Enable Injections, Inc. in Cincinnati seeks a Senior Supervisor, Packaging Operations to lead two shifts and translate production plans into staffing, equipment, and material priorities while ensuring safety, quality and on-time delivery.

The role requires GMP/ FDA packaging experience, expertise with automated equipment, SAP/ERP, and lean daily management; you will coach teams and drive continuous improvement across packaging processes.

Formación

• High school diploma or GED.
• Ability to read, write and communicate effectively in English.
• Minimum five years of production experience in a regulated environment with packaging ops.
• Experience managing production schedules, quality documentation, employee performance and metrics.
• Leadership in FDA-regulated packaging operations and GMP.
• Experience supervising two shifts including leads or frontline supervisors.
• Experience with automated packaging equipment, process validation, SAP or ERP, and lean daily management.

Responsabilidades

• Lead packaging operations across two production shifts to meet safety, quality, delivery and cost targets.
• Translate production plan into staffing, equipment and material priorities per shift.
• Own daily/weekly packaging output targets, labor productivity and downtime; address gaps and implement corrective actions.
• Provide visible floor leadership with structured daily management and shift handoffs.
• Ensure compliance with GMP, FDA requirements and quality-system controls.
• Review production records, packaging docs, label controls and reconciliations in real time.
• Identify deviations and support investigations and CAPA implementation.
• Coordinate with Maintenance and Engineering on equipment setup and improvements.
• Coordinate with Planning, Warehouse and Supply Chain for material availability and inventory transactions.
• Oversee staffing, scheduling, training and qualification across both shifts.
• Coach supervisors and technicians; provide feedback, evaluations and corrective counseling.
• Partner with Quality and Training on audits and training compliance.
• Drive continuous improvement using root cause analysis, standard work and lean practices.
• Maintain SAP/ERP transactions and administrative records.

Conocimientos

Floor leadership

Coaching

Employee development

Prioritize production demands

Communication across shifts

Problem solving

Data-driven decision making

Timekeeping systems

Cross-functional collaboration

GMP knowledge

Educación

Bachelor's degree in Business or Engineering

Herramientas

SAP

ERP systems

Microsoft Office

Descripción del empleo

Title: Senior Supervisor, Packaging Operations

Description

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 elevate 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 escalates 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.

Nearest Major Market: Cincinnati