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About the Role

The Senior Director, Facilities Engineering will lead the design, build, commissioning, and operational readiness of a new GMP gene therapy manufacturing suite. This role provides strategic leadership to the facilities and laboratory operations team, focusing on GMP-compliant facility engineering, project leadership, and team management.

Responsibilities

• Lead end-to-end design and construction of the clinical GMP gene therapy manufacturing suite.
• Partner with architects, specialist contractors, M&E engineers, and validation consultants to deliver GMP-compliant facilities.
• Oversee development of engineering and qualification deliverables for critical systems.
• Ensure facility design meets applicable regulatory requirements including EU GMP Annex 1, MHRA guidelines, and EMA guidance.
• Manage installation, commissioning, qualification, and handover of HVAC, cleanroom classifications, pressure differentials, environmental monitoring systems, utilities, and BMS/SCADA.
• Oversee contractor qualification, performance, and compliance.
• Lead installation, commissioning, qualification, and handover into routine GMP operation.
• Provide engineering leadership and technical input to the site Contamination Control Strategy.
• Establish and own the ongoing maintenance program for GMP manufacturing suite infrastructure.
• Ensure continuous facility compliance through change control, deviation management, and CAPA processes.
• Maintain all facility-related SOPs, logbooks, and controlled documentation.
• 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.
• Develop and oversee the continuous improvement of the facility.
• Provide senior oversight and strategic direction for corporate office and laboratory facilities operations.
• Set the strategic framework for health, safety, and environmental compliance.
• Own strategic vendor and estates relationships, including contract governance and service performance.
• Lead capital projects for office and laboratory spaces.
• Ensure integration between the GMP manufacturing programme and broader estate operations.
• Line manage and develop the facilities and engineering team.
• Set clear objectives, conduct performance reviews, and support professional development.
• Manage the facilities and engineering budget, including forecasting, procurement, and financial reporting.
• Represent the Engineering & Facilities function at senior leadership level.
• Champion continuous improvement initiatives across all facility operations.

Requirements

• Proven experience in a facilities, engineering and/or technical operations role within a GMP-regulated pharmaceutical, biotech, or cell & gene therapy environment.
• Proven track record of leading GMP facility design and build projects, from concept through to commissioning and regulatory approval.
• Demonstrated experience managing cleanroom facilities, HVAC systems, environmental monitoring, and critical utilities.
• Solid experience in facility qualification (DQ/IQ/OQ/PQ) and validation documentation.
• Experience leading, managing, and developing teams in a fast-paced, regulated environment.
• Strong project management skills with experience managing multiple workstreams and external contractors simultaneously.
• Experience managing facilities budgets and working within financial governance frameworks.
• Strong understanding of UK/EU health, safety, and environmental legislation applicable to laboratory and manufacturing environments.
• Highly organised with the capability to manage complex, concurrent workstreams and competing priorities.
• Collaborative approach with a customer-service mindset.
• Analytical and solutions-focused, with strong aptitude for problem-solving under pressure.
• Proficiency with facilities management and project management tools.
• Working knowledge of sterility assurance / contamination control principles relevant to facility design and operation.

Skills

• GMP regulatory frameworks (EU GMP Annex 1, MHRA, EMA, FDA)
• Cleanroom facilities management
• HVAC systems
• Environmental monitoring
• Critical utilities management
• Facility qualification (DQ/IQ/OQ/PQ)
• Validation documentation
• Team leadership and development
• Project management
• Budget management
• Financial governance
• UK/EU health, safety, and environmental legislation
• Facilities management tools
• Project management tools
• BMS/SCADA systems (advantageous)
• Leadership
• Interpersonal skills
• Communication skills
• Problem-solving

Location

• London, Hammersmith

Work Type

• Full-time

Experience Level

• Senior Director
• Senior

Education Level

• Degree in Engineering (Mechanical, Electrical, Chemical, or Biomedical), Life Sciences, or a closely related discipline
• Relevant professional qualifications (e.g., CIBSE, IWFM, IChemE) highly desirable

About the Company

• 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.

Equal Opportunity

• Orchard is an equal opportunity employer.
• We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees.
• We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination.
• We assess all applications on basis of job requirements and individual qualifications.
• We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
• Orchard Therapeutics participates in E-Verify.