Transfer & Validation Scientist (T&V)

BBI Group
Cardiff (Caerdydd)
£Competitive + Benefits
02 Jun 2017
30 Jun 2017
Transfer & Validation Scientist (T&V Scientist) Cardiff CF14 5DX / Crumlin NP11 3EF Permanent £Competitive BBI Solutions is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets. As a business, we are currently progressing through a substantial period of growth, and currently have the exciting opportunity for two Transfer & Validation Scientists (T&V) to join our growing operation. This role will initially be based from our Cardiff site, but will move to our brand new Global Centre of Excellence in Crumlin, by early 2018. The Role As the Transfer and Validation Scientist will work on development and transfer projects within BBI Solutions Cardiff. The position will involve supporting transfer and validation activities over multiple projects and working with all departments. Your role responsibilities will include but not be limited to the following: Supporting product transfer activities and subsequent validations. Transfer activities, to include: assessment of manufacturing process suitability, preparation of transfer to production plans and pilot batch protocols, ensuring appropriate training plans are in place for transfer phase, setting up Bill of Materials on SAGE, preparation of process FMEA’s. Executing validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives. Support the preparation of Validation Master Plans, Summary Reports and other required documentation for a validation exercise. Ensuring project work is carried out in compliance with regulatory and company requirements. Provide validation support and advice to other areas of the business as required. Ensuring good communication with the team and other departments and Sites as appropriate. Meeting agreed targets for project completion as defined by each project plan The Person As the T&V Scientist, you will be a strong communicator with the ability to build good working relationships, across departments and within project teams. It is key that you have the following experience: Experience in ISO13485. Experience interacting with auditors (internal and external) and supporting internal and external audits, overseeing the closure of gaps identified during the audits. Experience contributing to the development of regulatory documents and/or experience in reading regulatory documents You will need to have been training in Producing equipment qualification protocols and reports and are also trained in design control and risk management. It would be desirable that you also hold a Six Sigma DMAIC Green Belt Certification. During the recruitment process, you will be required to demonstrate previous experience in at least three of the following areas: process FMEA, product transfer, qualification, process, cleaning, analytical methods, lab equipment qualification, computer system validation, and Requalification. The Package The salary offering for this role is competitive and makes up part of BBI’s attractive benefits package, which includes: 5% contributory pension scheme. Life Assurance Private health care scheme. 28 days’ holidays (inclusive of bank holidays) with up to 4 additional days off, including 1 day for your birthday Participation in the childcare voucher and cycle to work schemes. The Company BBI is a fast-paced and agile business, with a track record of growth, and the opportunity to influence and direct the business going forward. We deliver exceptional products and technologies that people rely on to enjoy a better quality of life. We look for our people to be active participants in BBI life, to make work fun as well as challenging. This job was originally posted as