Senior Process Engineer - Sterile Polymer (Contract)
Core
Lead the development and implementation of a novel aseptic manufacturing process for biodegradable polymer-based implant products.
Role type
Senior Process Engineer (Sterile Polymer)
Builds
Biodegradable polymer-based implant products (pre-filled syringes, long-acting injectables)
Domain
Pharmaceutical / Medical Device Manufacturing
Required skills
Aseptic processing, Cleanroom design, Contamination control, Polymer extrusion, Crosslinking technologies, GMP validation, Equipment integration, Supplier management, Risk assessment, Process qualification
Preferred skills
Biodegradable polymers, Implantable products, Long-acting injectables, Pre-filled syringes, Advanced drug delivery technologies
Technologies
Open RABS, Laminar airflow, Extrusion, Crosslinking
Responsibilities
Develop detailed manufacturing process design, Define equipment requirements and process flow, Lead technical discussions with equipment vendors, Evaluate and optimize polymer preparation and extrusion technologies, Design aseptic operations in Grade A environments, Support facility layout and equipment integration, Coordinate installation activities and supplier deliverables, Work directly with the customer as primary engineering interface, Support GMP qualification activities (FAT, SAT, IQ, OQ, PQ), Ensure compliance with pharmaceutical GMP and aseptic processing requirements
Seniority
Senior, hands-on IC