Tangential Flow Filtration TFF Design and Project Lead

Title: Tangential Flow Filtration - TFF Design and Project Lead

Contract Role
Location: Boulder CO - 5 days Onsite

Requires 10 Years of Experience.

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
• Bachelors degree in either chemical engineering or mechanical engineering