Assembly & Packaging Lead / Manager
Core
Lead startup, commissioning, validation, and operational readiness for Assembly, Visual Inspection, and Packaging operations in pharmaceutical manufacturing.
Role type
Senior manufacturing operations lead (pharmaceutical assembly, inspection, packaging)
Builds
Drug products via assembly, visual inspection, and packaging lines
Domain
Pharmaceutical manufacturing (drug products)
Required skills
cGMP compliance, visual inspection, process validation, equipment lifecycle management, deviation/CAPA management, root cause investigation, regulatory inspection readiness, team leadership, project management
Preferred skills
NPI support, technology transfer, cross-functional collaboration, operational excellence, cost optimization
Technologies
GMP documentation systems, QMS tools, validation software
Responsibilities
Lead startup, commissioning, qualification, validation, and operational readiness for Assembly, Visual Inspection, and Packaging operations. Oversee equipment lifecycle management, including qualification, validation, maintenance, troubleshooting, and continuous improvement. Drive visual inspection programs, defect management, POD studies, QRA assessments, and process optimization. Lead investigations, deviations, CAPAs, risk assessments, and Change Controls to ensure product quality and compliance. Manage department resources, project timelines, and production priorities to meet business objectives. Serve as a key contact for customers, auditors, and regulatory authorities.
Seniority
Manager, hands-on IC with team leadership