Process Engineer - TFF SME

We are seeking a highly experienced Tangential Flow Filtration (TFF) Subject Matter Expert to provide technical leadership and support for pharmaceutical process development and manufacturing activities.

The ideal candidate will have deep, hands-on expertise in TFF process development, scale-up, optimization, troubleshooting, validation, and implementation within a regulated pharmaceutical environment. This individual should be capable of independently evaluating complex technical issues and developing practical, scientifically sound solutions.

• →Serve as the technical SME for TFF process development, scale-up, optimization, troubleshooting, and validation.
• →Develop and evaluate TFF processing strategies and operating approaches.
• →Assess critical process parameters, operating ranges, membrane selection, flux, pressure, concentration and diafiltration strategies, processing time, and other factors affecting process performance.
• →Support scale-up and implementation of TFF processes in GMP manufacturing environments.
• →Develop and support process characterization and validation strategies.
• →Provide technical input into protocols, reports, risk assessments, process descriptions, control strategies, and supporting documentation.
• →Provide technical support for regulatory interactions and responses related to process development, validation, and manufacturing strategy.
• →Troubleshoot filtration performance, membrane behavior, fouling, yield, process efficiency, and scale-up challenges.
• →Work directly with equipment, membrane, and system vendors to resolve technical issues and evaluate proposed solutions.
• →Collaborate with EH&S and other technical functions on applicable process safety and environmental considerations.
• →Work cross-functionally with Process Development, Manufacturing, Engineering, Validation, Quality, Regulatory, and other technical groups as required.

• Significant pharmaceutical industry experience with Tangential Flow Filtration, with sufficient technical depth to function independently as a TFF SME.
• Demonstrated experience developing, scaling, troubleshooting, and validating TFF processes.
• Strong knowledge of TFF system design, membrane selection, operating parameters, process characterization, scale-up principles, and filtration performance.
• Experience supporting GMP pharmaceutical manufacturing operations.
• Experience developing or supporting process validation strategies.
• Experience providing technical support for regulatory interactions, submissions, or responses involving pharmaceutical manufacturing processes.
• Demonstrated ability to work directly with equipment and membrane vendors and critically evaluate vendor recommendations.
• Strong technical problem-solving and troubleshooting capabilities.
• Ability to develop and defend scientifically sound technical recommendations.
• Strong cross-functional communication skills and the ability to work effectively with technical, quality, regulatory, engineering, and manufacturing organizations.

• Experience supporting complex pharmaceutical manufacturing processes.
• Experience with technology transfer and manufacturing process implementation.
• Experience supporting process characterization and process performance qualification activities.
• Experience with equipment design review, commissioning, qualification, and implementation.

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