Senior Engineer, Oral Solid Dose Packaging Development
Core
Lead end-to-end packaging material selection, engineering, and qualification for oral solid dose container closure systems and associated secondary/tertiary packaging from early clinical development through commercialization.
Role type
Senior IC packaging development engineer (oral solid dose)
Builds
Primary and secondary packaging systems for biopharmaceutical products
Domain
Biopharmaceuticals / Oral Solid Dose Packaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
oral solid dose packaging systems, container closure system development, packaging material selection, package integrity testing, transportation qualification, regulatory submission authoring, process validation, technology transfer, CPO management, packaging artwork development
Preferred skills
flexible-laminate packaging, parenteral packaging systems, moisture-sensitive product strategies, child-resistant packaging systems, commercial packaging site transfers
Technologies
cGMP, FDA/ICH/USP/ASTM/ISTA/ISO standards, serialization, barcodes
Responsibilities
Lead packaging strategies and specifications based on stability and regulatory requirements; Design and execute package integrity and validation studies; Lead technical assessments for contract packaging organization (CPO) selection and site readiness; Author regulatory packaging content for health authority submissions; Lead investigations for packaging deviations and nonconformances; Develop packaging artwork including dielines and print requirements
Seniority
Senior, hands-on IC
