Validation Engineer (Clean Room) in Hatfield

The role covers the full lifecycle of equipment development and transfer, from design definition through qualification, cleanroom introduction, and formal handover to manufacturing.

The consultant will work closely with the Client Tech Transfer team to ensure that equipment is technically robust, compliant, fit for cleanroom use, manufacturable at scale, and successfully embedded into routine manufacturing operations.

This role is intended for an experienced consultancy resource with a proven track record of transferring processes and bespoke equipment into regulated ISO8 cleanroom manufacturing environments.

Key Responsibilities

Equipment Definition & Design

• Work alongside the Tech Transfer team in Stevenage to develop User Requirement Specifications (URS) for bespoke and non bespoke equipment, driven by process scale-up and transfer needs.
• Perform risk assessments (e.g., HAZOP, 4E) across all phases of equipment design to ensure safety, compliance, and operability.
• Generate design drawings and P&IDs in line with URS requirements and lead structured design reviews with client stakeholders.
• Ensure equipment designs explicitly address cleanroom suitability, including cleanability, maintenance, operator interaction, and contamination control considerations.

Design Controls & Documentation

• Support the RFQ process by acting as technical interface with sourcing and suppliers, providing input during design iterations.
• Lead or support generation and review of design phase deliverables, including:
  • Functional Design Specification (FDS) – initial versions
  • Equipment and process risk assessments
  • First iteration drawings / P&IDs or physical prototypes (e.g., 3D printed)
  • CAD (2D) drawings with Critical to Quality (CTQ) characteristics
  • Design for manufacture, assembly, testing and serviceability (DFx)
• 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.
• 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:

• 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.