Lead the process design and technical strategy for peptide purification operations, including chromatography (prep-HPLC), filtration, crystallization, and lyophilization systems.
Own development and review of process design deliverables such as PFDs, P&IDs, mass balances, and equipment specifications to ensure scalability and GMP compliance.
Provide technical leadership in facility design and layout, ensuring optimal flow of materials, waste streams, and personnel while maintaining appropriate cleanroom classifications and contamination control.
Partner cross-functionally with MSAT, Process Development, Quality, Validation, Automation, and Capital Projects teams to align purification processes with overall facility and production goals.
Serve as the SME for purification technologies, guiding selection and implementation of equipment such as preparative HPLC skids, TFF systems, centrifuges, and lyophilizers.
Lead technology transfer activities for purification processes from development or pilot scale into commercial manufacturing.
Drive and facilitate risk assessments (FMEA, HAZOP) specific to purification unit operations, implementing mitigation strategies to ensure robust and compliant processes.
Oversee vendor engagement and design reviews, including URS development, technical bid evaluations, FAT/SAT execution, and issue resolution.
Define and implement process control strategies, including identification of CPPs, CQAs, and integration with automation systems (DCS/SCADA/MES).
Provide leadership and oversight for commissioning, qualification, and validation (CQV) activities, ensuring readiness for PPQ and commercial operations.
Review and approve GMP documentation, including SOPs, batch records, change controls, deviations, and CAPAs related to purification processes.
Support startup and engineering batches, providing hands-on troubleshooting and optimization of purification performance and yield.
Drive continuous improvement initiatives focused on process efficiency, throughput, solvent usage, and cost reduction.
Ensure all purification processes and systems meet global regulatory requirements (FDA, EMA, ICH) and internal quality standards.
Mentor and provide technical guidance to junior engineers and cross-functional team members.
Skills:
Prior experience as a purification design engineer in a GMP Pharma environment
Having design and built several purification step systems
Prior experience in working with and finalizing pipping scopes and sizing as appropriate
Prior experience in working with fabricator on skid build and deliver vendor selection valves and pipping
Experience in cytogenetic cooling systems and vacuum cooling control experience
Having supported commissioning and qualification team in startup environment
Support construction team in installation
Support a purification team of 8-10
Bachelors degree in Chemical Engineering or Mechanical Engineering
