Senior Purification Design Lead
IT Minds LLC, Boulder, CO, United States
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 piping scopes and sizing as appropriate
Prior experience in working with fabricator on skid build and deliver vendor selection valves and piping
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
Bachelor’s 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)
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:
Batch records
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
Professional Engineering Certification
Professional engineering certification
#J-18808-Ljbffr
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 piping scopes and sizing as appropriate
Prior experience in working with fabricator on skid build and deliver vendor selection valves and piping
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
Bachelor’s 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)
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:
Batch records
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
Professional Engineering Certification
Professional engineering certification
#J-18808-Ljbffr