To enable our Drug Development Solutions (DDS) business to continue to achieve our purpose of helping our customers develop new medicines and products to improve the quality of our patients' lives, we have an exciting opportunity for a CSV Engineer to join our Computer Systems Validation team, within our Drug Development Solutions team.
Our motivation is propelled by the constant drive to support our customers to help them win their fight against life threatening diseases, saving and improving the quality of lives around the world. We are passionately dedicated to the crucial part we play in making the world a better place and supporting a healthier life for all.
In this role you will be involved in all aspects of the computerised system validation life cycle – primarily for Analytical Instruments but including software used for other GxP work. This will include assessing computerised systems for compliance with applicable regulations, determining how to configure systems to meet business and regulatory requirements, preparation of validation documentation and supporting those performing the testing.
You will also be presented with the opportunity to be involved in the technical troubleshooting of the varied issues that can arise with computerised systems. This will require you to lead investigations drawing upon cross-department and external vendor support as necessary.
You will be supported by more experienced members of the team to develop in all aspects of the role, and you will work closely with several groups and functions – including Operations, Information Technology and Quality Assurance – to ensure systems are validated and operated in accordance with company procedures. This role will also include administration of some systems.
This role sits within our Computer Systems Validation Team and though the role is currently, for the most, distance based you will be expected to be available for work at either the Fordham, Cambridgeshire Site for training and either the Fordham or the Sandwich, Kent site more permanently in the future. The role may involve occasional travel to a between the two sites.
- Maintain a good working knowledge of GxP principles as applicable to system testing
- Work alongside Scientists to develop system requirements
- Write test plans, scripts and reports to demonstrate that requirements have been met
- Oversee the testing of systems and support the users executing the scripts
- Take a lead in resolving issues encountered during testing
- Work with the Quality Assurance team to ensure compliance expectations are met
- Troubleshoot and resolve system faults
- System Administration
- You will be working closely with our QA and IT validation specialists; so excellent people and collaborative skills will be required
Education, experience and technical skills:
- Aptitude towards computer systems, ideally including analytical instrument control software
- Experience of software testing
- Knowledge of GxP regulations relating to computerised systems plus 21 CFR part 11
- Knowledge of GAMP 5
- Detailed, methodical and consistent approach
- Previous experience of working in a GxP environment and/or previous experience of manual software testing, particularly document writing and test scripts is essential
- Previous experience as a System Owner in a GxP regulated environment is advantageous but not essential
- Previous experience providing technical support for computerised systems in a GxP regulated environment is advantageous but not essentia
- A ‘can-do’ proactive attitude with a willingness to expand your knowledge base
- A real problem solver with the ability to work as part of a team or individually
- Good project and time management skills are essential to ensure all aspects of CSV project work is kept on track
- A self-starter with excellent communication skills