Process Design Lead

Key Responsibilities

• Serve as the primary technical liaison between the client and engineering/design partners
• Represent the client in design reviews, workshops, and technical discussions
• Critically review design deliverables to ensure alignment with client standards, URS, and industry best practices
• Provide clear, timely, and actionable feedback to design teams
• Drive balanced decisions across cost, schedule, quality, and compliance
• Review and approve key design documents, including:
• Process Flow Diagrams (PFDs)
• Piping & Instrumentation Diagrams (P&IDs)
• Equipment layouts and facility arrangements
• Lead and support development of User Requirements Specifications (URS)
• Ensure designs incorporate:
• Aseptic processing principles
• Contamination Control Strategies (CCS)
• Radiological requirements (FDA, EU Annex 1, etc.)
• Act as Engineer of Record for assigned process packages
• Provide subject matter expertise and technical ownership for:
• Vial filling and capping systems
• Syringe filling and closing systems (including nested formats)
• Supporting equipment:
• Debaggers
• E-beam sterilization systems
• Isolators (filling and material transfer)
• Autoclaves
• Inspect and test systems:
• Container Closure Integrity Testing (CCIT)
• Visual inspection lines
• Ensure seamless integration across upstream/downstream systems and utilities
• Collaborate with process, automation, facilities, and QA teams for cohesive system design
• Identify and mitigate design risks early in the project lifecycle
• Support technology selection and vendor alignment
• Ensure designs support aseptic assurance, sterility, and regulatory compliance
• Promote best practices in cleanability, sterilization, and environmental control
• Support development of contamination control strategies and risk assessments (e.g., FMEA)