Senior Validation Specialist

Reporting to the Validation Manager, the Senior Validation Specialist will be responsible for leading validation, qualification and verification of manufacturing equipment, facilities and laboratory systems in accordance with GMP Regulation. Your role will involve authoring, executing and reporting on validation activities within GMP using Annex 11 and 15 and in compliance with the QMS requirements. This role will support multiple projects, liaising with the project teams and other departments to ensure validation status is maintained Additionally, you will have the opportunity to deputise for the Validation Manager, as needed.,

• Supporting the implementation of a risk-based approach to the validation of systems to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP 5 guidelines, along with company quality documents and guidelines.


• Preparing and maintaining validation plans, assisting system owners with impact assessments, risk assessments and identifying validation requirements for equipment, facility and systems projects.


• Preparing and executing validation protocols for equipment, facilities, utilities, computerised systems, and processes. Including aspects of system security and electronic signatures in accordance with Annex 11/Part 11 and Data Integrity guidance.


• Managing requalification of systems and equipment


• Supervising validation testing performed by vendors to ensure work is complete and accurate


• Undertake validation project execution in conjunction with relevant stakeholders ensuring timelines and deliverables are achieved.
  
  We are currently seeking a highly experienced and dedicated Senior Validation Specialist to join our Validation team., BSc or MSc in a life science subject or comparable experience


• Experience leading qualification / validation activities within the biopharmaceutical ATMP or related sectors (e.g cleanrooms, production/ lab equipment, monitoring systems)


• Demonstrable experience of generation and execution of validation lifecycle documents in adherence to Annex 11 and Annex 15.


• Experience of successful interaction with multifunctional project teams and external contracted resources to develop requirements, establish programs and complete the validation


• Knowledge and understanding of implementation of GAMP and Data Integrity guidance


• Understanding and experience of Aseptic processing and cleanroom operation


• Knowledge of relevant regulations (FDA, EMA, ICH) and interaction with regulatory authorities during inspections.
  
  Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products.
  
  The is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.