We are seeking an experienced and professional Validation Manager to direct the Validation Team at our GMP facility. Company Information 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 highly personalised therapies. Job Summary Based on-site in Sawston, the Validation Manager will be responsible for ensuring validation activities associated with manufacturing and lab equipment, facilities, utilities, laboratory and company computer systems are completed in accordance with GMP requirements. The role will be responsible for leading the Validation function and the day to day managing growth and development of the validation team. You will support multiple validation projects, liaising with department heads, project teams and associated departments who contribute to validation objectives. Responsibilities will include: Support 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. Input into User Requirement Specifications. Preparation and execution of validation protocols for equipment, facilities and utilities. Including aspects of system security and electronic signatures in accordance with Annex 11/Part 11 and Data Integrity guidance. Oversight of qualification of cleanroom processes in accordance with industry guidance. Manage the requalification of systems and equipment in accordance with approved plans and procedures to maintain the ‘validated state’. Executing validation protocols for equipment, facilities, utilities. Managing the requalification of systems and equipment in accordance with approved plans and procedures to maintain the ‘validated state’. Supervise validation testing performed by vendors to ensure work is complete and accurate, critically review results of validation studies and work with vendors for issue resolution and validation deviation reporting. Full line management responsibility for the validation team, including recruitment, professional development, coaching and performance. Develop and maintain the departmental training program to ensure the team is competent and up-to-date with current regulations and industry guidance (e.g., Annex 11, Annex 15, GAMP 5). Supporting the team with day to day operations. You will have the following experience/qualifications: A Degree (or equivalent) in a Science or related discipline. Qualifications related to validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines). Significant experience leading qualification/validation activities within the biopharmaceutical, ATMP or related sectors. A strong track record of establishing validation master plans (VMPs) and associated systems which facilitate the delivery of qualification/validation activities to the required quality and regulatory standards. Demonstrable experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation/execution of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical or related industry. Understanding and experience of aseptic processing and cleanroom technologies. Experience of successful interfacing with Facilities, Quality, Operations, Information Technology and external contracted resources to develop requirements, establish programs and manage day-to-day operation. Experience in interacting with the regulatory authorities. Knowledge of relevant regulations including FDA, EMA, ICH. Experience in interacting with clients and collaborators. Excellent interpersonal skills and excellent IT skills Excellent attention to detail, adherence to SOPs and record keeping Self-motivated with strong initiative and drive We are not accepting agency applications for this role.