Senior Engineer
Core
Develop and validate pharmaceutical packaging materials and manufacturing processes for large and small molecules, ensuring cGMP compliance and technology transfer from clinical to commercial stages.
Role type
Senior Engineer (Pharmaceutical Packaging & Process Development)
Builds
Pharmaceutical dosage forms and packaging components for Oncology, Inflammation, General Medicine, and Rare Disease therapeutic areas.
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, technical evaluation of packaging materials, technology transfer, IQ/OQ/PQ qualification, CAPA implementation, scientific data analysis, regulatory documentation, batch manufacturing execution
Preferred skills
Experience with Trackwise, IDM, or OCM systems, knowledge of solid dosage forms, multi-functional team collaboration
Technologies
Trackwise, Integrated Document Management (IDM), Organizational Change Management (OCM)
Responsibilities
Write test protocols and technical specifications; Evaluate and select new packaging materials; Assess complex material problems and implement solutions; Lead technology transfer for packaging components; Manage project priorities and due dates; Present new packaging concepts to the Product Development team; Ensure cGMP and regulatory compliance with Quality Assurance and Regulatory teams
Seniority
Senior, hands-on IC
