Process Engineer, Manufacturing Science and Technology
1 week ago
As a Process Engineer at Forge Biologics, you will be responsible for developing, optimizing, and supporting gene therapy manufacturing processes within our Manufacturing Science and Technology (MS&T) team.
This is a multidisciplinary position, and you will work closely with cross-functional teams, including R&D, manufacturing, quality, and regulatory teams, to ensure that upstream, downstream, and fill finish processes are scalable, robust, and compliant with regulatory requirements.
This role focuses on feasibility evaluation, design, implementation, and documentation of engineering studies to support continuous improvement of processes towards the goals of process validation and the commercial manufacturing of gene therapy products.
Process Engineering also provides technical support and troubleshooting for assigned processes and equipment in the cGMP biological manufacturing areas, ensuring that all improvements are sustainable and aligned with overall business goals.
Key Responsibilities- Provide technical support for process improvement and technology transfer activities involving cross-functional teams including Manufacturing, Quality, and Process Development.
- Identify and implement continuous process optimizations, automation, new technology, critical reagents, and material selection initiatives to drive operational efficiency, reduce costs, and enhance product consistency.
- Partner with clients and internal cross-functional teams in technology transfer plans, gap analysis, mapping of process flows, and PFMEAs to ensure smooth and efficient technology transfer of gene therapy processes into manufacturing.
- Assist in the development of project justification, engineering proposals, and capital planning processes, including drafting URS and SIA documentation, facilities and equipment selection, and development of maintenance and training plans.
- Support for process qualification and validation preparation, execution, monitoring, and reporting.
- Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP).
- Develop and maintain external technical relationships with equipment and material suppliers to assist in the scheduling of training, repairs, maintenance of manufacturing equipment and to procure supplies and spare parts.
- Support the development of technical documents such as study plans, manufacturing batch records, and SOPs, protocols, and reports.
- Assist in investigations, document findings and maintain accurate records of all investigations, ensuring timely resolution of deviations.
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