Senior Specialist, Engineering - Oral Solid Dose Packaging
Core
Senior engineer providing technical support, design, and validation for oral solid dose and medical device packaging lines at a manufacturing site.
Role type
Senior Specialist, Packaging Engineering (Pharmaceutical/Medical Device)
Builds
Bottle/blister/autoinjector packaging lines and medical device assembly equipment
Domain
Pharmaceutical manufacturing / Medical device assembly
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Packaging engineering, GMP compliance, Equipment qualification, Process validation, Root cause analysis, Regulatory documentation, Scale-up technology transfer, Mechanical troubleshooting
Preferred skills
Autoinjector assembly expertise, Lean Six Sigma, Project management
Technologies
Packaging equipment, Autoinjector assembly lines, Process validation tools
Responsibilities
Lead scale-up and technology transfer of pilot processes to production scale; Manage capital projects for new equipment installation and qualification; Troubleshoot equipment issues and lead root cause analysis; Author process change controls and validate process modifications; Support quality and regulatory activities including FDA inspections; Evaluate quality specifications for raw and final products.
Seniority
Senior, hands-on IC with leadership responsibilities
