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.
Job Summary
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.
Key Responsibilities
GMP Manufacturing Suite — Design, Build & Commissioning
- 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.
Engineering Operations — GMP Manufacturing Suite
- 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.
Corporate Office & Laboratory Facilities Management
- 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 framework for health, safety, and environmental compliance across all managed buildings; hold senior accountability for regulatory standards while the Health & Safety Manager leads day-to-day implementation and risk management.
- Own the strategic vendor and estates relationships, including contract governance and service performance frameworks; support the Facilities & Laboratory Operations Manager in ensuring service quality and value for money across all providers.
- Lead capital projects for office and laboratory spaces, including fit-out, refurbishment, and relocation programmes, ensuring alignment with business needs, budget, and regulatory requirements.
- Ensure integration between the GMP manufacturing programme and broader estate operations, so that lessons learned, standards, and compliance practices are appropriately shared across the facilities function.
Leadership & People Management
- Line manage and develop the facilities and engineering team, fostering a high-performance, safety-first culture.
- Set clear objectives, conduct performance reviews, and support professional development across the team.
- Manage the facilities and engineering budget, including forecasting, procurement, invoicing oversight, and financial reporting, ensuring expenditure aligns with business priorities and cost controls.
- Represent the Engineering & Facilities function at senior leadership level, providing regular updates on project progress, operational performance, and compliance status.
- Champion continuous improvement initiatives across all facility operations.
Requirements
Experience, Skills & Knowledge:- 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.
- In-depth knowledge of GMP regulatory frameworks including EU GMP Annex 1, MHRA, and EMA requirements.
- 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.
- Deep technical knowledge of GMP engineering systems: HVAC, cleanrooms, utilities, BMS, and environmental monitoring.
- Strong understanding of UK/EU health, safety, and environmental legislation applicable to laboratory and manufacturing environments.
- Excellent leadership and interpersonal skills with the ability to influence across all levels of the organisation.
- Highly organised and the capability to manage complex, concurrent workstreams and competing priorities.
- Clear and confident communicator — able to convey technical information effectively to non-technical stakeholders.
- Collaborative approach with a customer-service mindset; able to build strong relationships with internal stakeholders and external partners.
- Analytical and solutions-focused, with strong aptitude for problem-solving under pressure.
- Proficiency with facilities management and project management tools; familiarity with BMS/SCADA systems advantageous.
- In-depth knowledge of GMP regulatory frameworks including EU GMP Annex 1, MHRA, EMA and FDA requirements
- Working knowledge of sterility assurance / contamination control principles relevant to facility design and operation.
Education:- 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.
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.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
RECRUITERS
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.
