Senior Supervisor, Packaging Operations

Enable Injections; Cincinnati (OH); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Cintrifuse is seeking an experienced Packaging Operations Leader to oversee two shifts in a regulated manufacturing environment. You will translate production plans into staffing, equipment, and material priorities while ensuring GMP compliance and accurate recordkeeping.

Responsibilities include driving on-time packaging output, improving labor productivity, coordinating with Quality, Maintenance and Planning, and leading a team through coaching and formal evaluations.

Qualifikationen

• 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.
• 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.

Aufgaben

• 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; 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 and handoffs.
• Ensure packaging activities comply with procedures, GMP, FDA requirements and quality-system controls.
• Verify timely and accurate completion and review of production records, packaging documentation, label controls, line clearances and reconciliations.
• Identify, contain and escalate deviations, nonconforming product, documentation discrepancies and quality issues; support investigations and CAPA implementation.
• Ensure equipment is cleaned and maintained; partner with Maintenance and Engineering on troubleshooting and improvements.
• Coordinate with Planning, Warehouse and Supply Chain for material availability and inventory transactions.
• Own staffing plans, scheduling, attendance, hiring, onboarding and qualification across both shifts; ensure coverage of critical packaging processes.
• Coach and develop technicians, team leads and staff; provide feedback and formal evaluations.
• Partner with Quality and Training to maintain training compliance and audits readiness.
• Champion continuous improvement using root-cause analysis, standard work and lean daily management.
• Initiate or support document revisions, change controls, nonconformances and CAPAs.
• Maintain SAP/ERP production, inventory and labor transactions and complete administrative records.
• Elevate operational risks and recovery plans with leadership, across shifts.
• Coordinate with upstream manufacturing and distribution activities to ensure product flow.

Kenntnisse

Floor leadership

Coaching

Shift leadership

Data-driven

Communication

Packaging operations

Troubleshooting

Ausbildung

High school diploma or GED

Bachelor’s degree in Business/Engineering/Operations Management

Tools

SAP

ERP systems

Timekeeping systems

Microsoft Office

Jobbeschreibung

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.