Senior Director, Facilities Engineering

Location : London, Hammersmith

Reporting to : Chief Technical Officer

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.

The Senior Director, Facilities Engineering will spearhead the design, build, commissioning, qualification, handover and operational readiness of our new clinical-stage GMP gene therapy manufacturing suite, while also providing strategic leadership to the facilities and laboratory operations team. This is a high-impact role at the heart of our growth as a gene therapy company, requiring deep expertise in GMP-compliant facility engineering, strong project leadership, and the ability to manage and develop a multidisciplinary facilities team.

• Lead end-to-end design and construction of the clinical GMP gene therapy manufacturing suite, acting as the primary internal owner and technical authority throughout the project lifecycle.
• Partner with architects, specialist contractors, mechanical and electrical (M&E) engineers, and validation consultants to deliver GMP-compliant facilities on time and within budget.
• Oversee development of engineering and qualification deliverables for all critical systems, including URS input, design reviews, commissioning, qualification and validation documentation, and activities required to support handover and maintenance of the qualified state.
• Ensure the facility design meets applicable regulatory requirements including EU GMP Annex 1, MHRA guidelines, EMA guidance, and other relevant international standards.
• Manage the installation, commissioning, qualification support and handover of HVAC, cleanroom classifications, pressure differentials, environmental monitoring systems, utilities, and building management systems (e.g. BMS/SCADA).
• Oversee contractor qualification, performance, and compliance throughout design and build phases.
• Lead installation, commissioning, qualification, and a successful handover into routine GMP operation in collaboration with QA and Manufacturing, ensuring maintenance strategy, asset care, calibration, vendor support, spare parts, alarm response, and engineering ownership are established for run-state operation.
• Provide engineering leadership and technical input to the site Contamination Control Strategy, including cleanroom zoning, HVAC strategy, pressure cascades, barrier infrastructure, environmental monitoring infrastructure, and other facility design decisions relevant to sterility assurance and contamination control.

• Establish and own the ongoing maintenance program for GMP manufacturing suite infrastructure, including preventative, corrective, and planned maintenance of all critical systems and equipment, supporting GMP compliance and maintenance of the qualified/validated state.
• Ensure continuous facility compliance through robust change control, deviation management, and CAPA processes in partnership with Quality Assurance.
• Maintain all facility-related SOPs, logbooks, and controlled documentation in line with GMP requirements.
• Serve as the primary point of contact for regulatory inspections and audits relating to facility infrastructure and engineering systems.
• Own the engineering response to environmental monitoring and facility system excursions, including EMS, HVAC, alarms, and infrastructure-related investigations, in partnership with EM programme management.
• Develop and oversee the continuous improvement of the facility through optimization and feedback from the manufacturing team.

• Provide senior oversight and strategic direction for all corporate office and laboratory facilities operations, working through the Facilities & Laboratory Operations Manager and Health & Safety Manager to ensure consistently high standards across the estate.
• Set the strategic…