Validation Specialist

Our clients are looking for driven individuals to join as Validation Specialist as part of continued growth and success. These are exciting opportunities to join an industry-leading ATMP manufacturer at a time of exciting growth and development and are well suited to QA professionals looking to gain ATMP experience.

Our clients are a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

The Role:

You will be a key member of our Validation team and will use your GMP Validation background and knowledge to support our facility and equipment validation activities including the preparation and execution of validation protocols and reports.

Responsibilities:

Your responsibilities will therefore be varied, but will include;

· Planning, co-ordinating and executing (as appropriate), validation activities including facility and equipment validation, qualification and re-verification.

· Completion and review of quality related documentation including validation documents, change controls, incidents/deviations and risk assessments in line with GMP and SOPs.

· Preparation and execution of validation protocols and reports.

· Contribution to the set up and execution of the Validation schedules, including the development and maintenance of the Validation Master Plan.

· Development and implementation of process improvements relating to Validation activities.

· Assisting with the procurement and management of out-sourced Validation and qualification service providers.

· Ensuring Validation and re-qualification schedules are co-ordinated and communicated.

· Routine maintenance of KPIs and data to enable reporting on Validation status and performance of Validation activities.

· With the Validation team, providing regular reports to management on Validation activities.

Qualifications:

You will hold a BSc in a Life Science or a related subject or equivalent relevant experience.

Skills and Experience:

You will be able to demonstrate:

· Experience working in Validation within a GMP biologics or pharmaceutical environment.

· Demonstrable experience in managing a Validation programme in a GMP environment, preferably within a sterile Manufacturing facility.

· Excellent skills in Microsoft Office and an electronic quality management package.