Senior Packaging Supervisor

Enable Injections, Inc.Cincinnati, OhioOn-siteFull-timeSenior, 5–8 yearsListed 13 hours ago

Apply now

About this role

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 escalate 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 escalate 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.