Supplier Management & Design Qualification

• Facilitate design reviews with external equipment vendors, ensuring cross-functional input from EHS, QA, R&D SMEs, Validation, and Operations.
• Prepare the Design Qualification (DQ) Report, including conformity assessment, at design freeze and design for manufacture approval with the Tech Transfer team.
• Project manage equipment manufacture, tracking supplier progress, managing technical queries, and escalating risks or delays to the Tech Transfer team.

Commissioning, Qualification & Cleanroom Transfer

• Lead and execute Factory Acceptance Testing (FAT), including authoring commissioning protocols and ensuring complete supplier documentation packages (manuals, SOPs, drawings).
• Lead and execute Site Acceptance Testing (SAT) and associated commissioning activities with SMEs and Tech Transfer team.
• Confirm process capability and robustness prior to formal handover to manufacturing.
• Author Installation Qualification (IQ) plans and reports, including confirmation of supplier commissioning and EAM setup.
• Collaborate with R&D and Tech Transfer SMEs to define development activities and convert outcomes into manufacturing-ready SOPs.
• Author Operational Qualification (OQ) plans and reports for cleanroom manufacturing equipment.
• Ensure all equipment-related deliverables are completed and approved prior to progression into PQ / PV.
• Support resolution of post handover issues and contribute to lessons learned and continuous improvement activities.

Cross Functional Interaction

The consultant will work closely with:

• Tech Transfer
• Strategic Sourcing and Equipment Suppliers

Required Skills, Experience & Expertise

Consultancy & Industry Experience

• Consultant from an engineering or life sciences consultancy with demonstrable experience delivering equipment into GMP regulated cleanroom manufacturing environments.
• Strong background in equipment development and tech transfer within regulated industries (e.g. biopharma, medical devices, diagnostics).
• Direct experience transferring bespoke, low volume, and scaled equipment from development into manufacturing cleanrooms.

Technical & Regulatory Skills

• Can create 2D, 3D CAD models and P&IDs of equipment based on URS basic requirements.
• Expert understanding of design control, URS development, and qualification principles (DQ, FAT, SAT, IQ, OQ, PQ).
• Proven capability generating and reviewing engineering documentation, including drawings, P&IDs, risk assessments, and qualification packs.
• Practical, hands-on experience executing FAT and SAT with suppliers.
• Strong understanding of cleanroom equipment design, including contamination control, cleanability, maintainability, and operator interaction.
• Experience working across multiple scales of operation (small, intermediate, and large-scale throughput).

Ways of Working

• Highly structured and process-driven approach, aligned to formal development and validation frameworks.
• Confident cross-functional operator with strong stakeholder engagement skills across R&D, QA, validation, and operations.
• Comfortable taking end-to-end accountability for delivery, not just technical contribution.
• Able to balance speed to implementation with compliance, safety, and robustness.