Engineering Validation Specialist
MeiraGTxLondon, England, United Kingdom
Posted October 14, 2025
Full Time
About the Company
MeiraGTx is a clinical-stage genetic medicine company with a broad pipeline of late-stage programs supported by end-to-end manufacturing capabilities. The company focuses on viral vector design, optimization, and a transformative riboswitch gene regulation platform that enables precise, dose-responsive control of gene expression through oral small molecules. MeiraGTx targets metabolic peptides for diseases like diabetes and autoimmune conditions, expanding genetic medicine applications to common ailments while addressing unmet needs in large disease areas.
Job Description
This Engineering Validation Specialist role provides ongoing support for the validation of MeiraGTx processes, equipment, facilities, and computerised systems, ensuring compliance with EU and FDA regulations. The role involves maintaining GMP documentation, reviewing qualification protocols, and supporting QMS activities, acting as a subject matter expert in validation and computerised systems.
Requirements
- Adequately provide support and oversight to activities related to validation, and computerised systems, activities, ensuring compliance with EU, UK and FDA GxP regulatory requirements, MeiraGTx QMS and any other applicable regulations/standards.
- Maintain an understanding of cGMP, GEP (Good Engineering Practice), computerised systems validation, and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
- Act as reviewer/ approver for MeiraGTx Policies, and SOPs, that govern the MeiraGTx validation and computerised systems requirements.
- Interface with other departments such as QA, Facilities, Laboratories, Operations, Warehouse, IT, and Process Development to ensure that validation project plans are understood and in keeping with site objectives.