Sr. Engineer, Packaging
Core
Sr. Engineer providing operational support for commercial Contract Packaging Organizations (CPOs) within the biopharmaceutical supply chain, managing serialization, supplier oversight, and production quality.
Role type
Senior IC packaging engineer (pharma supply chain)
Builds
Commercial packaging operations and serialization compliance for biopharmaceutical products
Domain
Biopharmaceuticals / Packaging Engineering / Supply Chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Packaging engineering, cGMP compliance, serialization management, supplier management, project management, root cause analysis, validation activities, regulatory knowledge (DSCSA), document management
Preferred skills
Biologics experience, parenteral drug product experience, TraceLink proficiency, Veeva familiarity
Technologies
TraceLink, Veeva
Responsibilities
Manage supplier scorecards and business reviews; Monitor TraceLink transaction processing and EPCIS data; Develop serialization requirements for new products; Review pre- and post-production documents; Support deviation and product complaint root cause analysis; Participate in validation activities at CPOs; Prepare RFQs, RFPs, and Supply Agreements; Provide Person-in-Plant coverage for critical production activities.
Seniority
Senior, hands-on IC
