Process Engineer - TFF SME

CONTRACT WORK:

Position Summary 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.