Senior Purification Design Lead

Role: Senior Purification Design Lead SME

Location: Boulder Colorado

Day to day responsibilities:

• 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

 Tangential Flow Filtration - TFF Design and Project Lead

Daily duties of the contractor?

• Support the end-to-end design and development of peptide manufacturing processes, ensuring alignment with cGMP requirements, regulatory expectations, and industry best practices.
• Collaborate cross-functionally with process development, MSAT, quality, validation, engineering, and project management teams to translate process requirements into scalable manufacturing solutions.
•  Lead and contribute to process design activities, including:

·      Process flow diagrams (PFDs)

·      Piping & instrumentation diagrams (P&IDs)

·      Mass and energy balances

·      Equipment sizing and selection

• Provide technical input during facility design and layout planning, ensuring efficient material/personnel flow, contamination control strategies, and compliance with GMP zoning and cleanroom classifications.
• Support technology transfer activities from R&D or pilot scale into commercial manufacturing, ensuring process robustness and reproducibility.
• Participate in risk assessments (e.g., FMEA, HAZOP) to identify and mitigate process and design risks.
• Develop and review user requirement specifications (URS), functional specifications (FS), and design qualification (DQ) documentation for process equipment and systems.
• Interface with equipment vendors and engineering firms, supporting design reviews, factory acceptance testing (FAT), and site acceptance testing (SAT).
• Assist in establishing process control strategies, including critical process parameters (CPPs), critical quality attributes (CQAs), and automation requirements.
• Support commissioning, qualification, and validation (CQV) activities, including:
• IQ/OQ/PQ protocol development and execution
• Process validation (PPQ) readiness
• Engineering batch support
• Author and review GMP documentation, including:

·      Standard Operating Procedures (SOPs)

·      Batch records

·      Change controls

·      Deviations and CAPAs

• Monitor and troubleshoot process performance during startup and initial manufacturing campaigns, driving continuous improvement initiatives.
• Ensure compliance with regulatory standards (FDA, EMA, ICH) and internal quality systems throughout design and implementation phases.
• Participate in project meetings and design reviews, providing updates on process engineering deliverables, timelines, and risks.
• Support implementation of digital systems and automation platforms (e.g., MES, SCADA, DCS) for peptide manufacturing processes.

Required Skills:

• 7-10 plus years of experience as a process design engineer in a pharmaceutical GMP environment
• Has process design engineering experience as a lead or individual team member
• Having worked on peptide projects before
• Has been a member of design team for 2-3 Tangential Flow Filtration (TFF) process skids projects

• Ability to spec, size and design peptide process trains

·      In particular – Purification and TFF - Tangential Flow Filtration

• Prior experience working with fabricator on skid build and deliver
• Supporting commissioning and qualification team in startup
• Prior experience supporting construction teams in installation
• Bachelor’s degree in either chemical engineering or mechanical engineering

Desired:

Professional engineering Certification

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |