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Job Title: Packaging Manager Inhalation / MDI (Pharmaceutical Manufacturing) Location: Fall River, Massachusetts, USA (Onsite) Work Schedule: General: 8:30 AM 5:00 PM (May vary based on business needs; shift flexibility required) Employment Type: Full-Time | Exempt (Professional) Salary Range: (Based on Experience) (Relocation support may be available) Position Overview We are seeking an experienced Packaging Manager Inhalation/MDI to lead and manage pharmaceutical packaging operations in a cGMP-regulated manufacturing environment . This role is critical in ensuring safe, compliant, and on-time packaging of Metered Dose Inhaler (MDI) products , while driving operational excellence, team development, and continuous improvement. This is a hands-on people manager role , not a desk-based position. Key Responsibilities Packaging Operations & Production Plan, monitor, and control daily packaging activities to meet production targets, quality standards, and timelines Review planned vs. actual production and adjust schedules as required Ensure availability of packaging materials, components, consumables, and spare parts across all shifts Drive execution of new product introductions and technology transfers through gap analysis Optimize utilization of packaging equipment, consumables, and manpower Quality, Compliance & cGMP Ensure all packaging activities comply with cGMP, safety, and regulatory requirements Review in-process controls and packaging documentation to ensure right-first-time execution Lead and support investigations including deviations, OOS, OOT, complaints, and CAPAs Prepare, review, and maintain SOPs, BMRs, APQRs, validation, and qualification documents Support internal, external, and regulatory audits (including USFDA inspections) Equipment, Engineering & Continuous Improvement Coordinate with Engineering and Maintenance for preventive maintenance and breakdown resolution Monitor OEE / OOE data and implement PDCA-based improvements Drive packaging excellence initiatives to improve yield, reduce downtime, and minimize losses Identify bottlenecks and develop capacity utilization plans People Management & Safety Lead, train, and manage packaging teams across multiple shifts (15 direct / ~45 total staff) Ensure adequate staffing, shift planning, and effective manpower utilization Train teams on SOPs, GMP, safety, and new processes Promote a strong safety culture; ensure PPE compliance and safe work practices Education & Experience Education Bachelors degree in Pharmaceutical Manufacturing, Industrial Engineering, or related discipline preferred Experience 59 years of pharmaceutical packaging experience in a cGMP environment Minimum 3+ years in a supervisory or managerial role Hands-on experience with MDI (Inhalation) packaging lines is required Direct exposure to USFDA and regulatory audits Experience with SAP and manufacturing systems is a plus Required Competencies Strong knowledge of pharmaceutical packaging operations and MDI products Expertise in GMP documentation and compliance Proven troubleshooting, investigation, and root cause analysis skills Effective leadership, communication, and cross-functional collaboration Comfortable working in a fast-paced, regulated manufacturing environment Working Conditions Onsite role in a pharmaceutical manufacturing environment PPE required (gowning, safety equipment, respiratory protection as applicable) Shift flexibility, including occasional weekends or holidays based on business needs No remote work available