M
Senior Process and Systems Engineer
במקום העבודהמשרה מלאהIndustrial EngineeringPharmaceutical Manufacturing
A biopharmaceutical manufacturer seeks an experienced engineer to support, improve, validate, and scale GMP manufacturing processes across technology transfer, process development, and engineering operations.
תחומי אחריות
- Lead technology transfer and production process scale-up, including process improvement, data preservation, protocol development, and documentation.
- Prepare technology transfer documents, protocols, reports, and gap analyses in line with applicable guidelines.
- Support engineering policies and implementation while continuously improving existing and new processes.
- Develop process control strategies using automation and advanced analytics to improve manufacturing consistency and scalability.
- Support planning and execution of process and equipment validation.
- Initiate and execute change requests, deviations, and corrective actions within company quality systems.
- Coordinate with engineering, validation, quality, manufacturing, and external subcontractors to deliver engineering projects on schedule and within resources.
- Optimize biopharmaceutical manufacturing processes, including ultrafiltration, lyophilization, and fill-finish operations.
- Apply process modeling, data analysis, and control systems design to improve scalable and cost-effective production.
- Ensure process and engineering designs comply with FDA, EMA, ICH, and cGMP requirements and remain audit-ready.
דרישות
- Bachelor’s, master’s, or doctoral degree in chemical engineering, biochemical engineering, mechanical engineering, or a related engineering discipline.
- At least 7 years of process engineering experience in pharmaceutical or biopharmaceutical manufacturing.
- Hands-on experience with cleanrooms and GMP production areas.
- Experience managing complex engineering projects in regulated environments.
- Expertise in process development, scale-up, optimization, validation, and commercial manufacturing equipment.
- Strong knowledge of FDA, EMA, ICH, and cGMP requirements.
- Experience leading production process technology transfers in the pharmaceutical industry or an equivalent environment.
יתרון
- Experience with aseptic processing, powder handling, and isolator technology.
- Experience with lyophilization, ultrafiltration, and fill-finish processes and equipment.