External Manufacturing Project Specialist, Serialization
Core
Drive compliant global product launches and ensure end-to-end serialization and track-and-trace readiness for new and transferred products.
Role type
Project Specialist (Serialization)
Builds
Serialization systems, integrations, and track-and-trace platforms for global markets
Domain
Pharmaceutical manufacturing, serialization, and regulatory compliance
Required skills
Project management, serialization system operations, validation activities, quality event support, regulatory compliance knowledge, partner coordination, data flow troubleshooting, change control management
Preferred skills
Global standards knowledge, emerging regulations familiarity, technical transfer experience, risk assessment
Technologies
Tracelink, EPCIS, EDI, CSV tools
Responsibilities
Ensure serialization readiness for new/transferred products, coordinate labeling and master data with partners, complete readiness checks and qualification runs, support investigations and quality events, maintain audit-ready records, implement corrective actions, operate track-and-trace platforms, troubleshoot data flow issues, plan CSV activities, support technical transfers, own change controls, serve as liaison with external partners, communicate timelines and risks, apply PM techniques to deliver sub-projects
Seniority
Specialist (2+ years experience) to Sr Specialist (5+ years experience)
