Validation Analyst – Sterilisation and Aseptic Processing
Based within the Validation Department, the successful candidate will be involved in validation of sterilisation and depyrogenation processes, validation of aseptic manufacturing and filling procedures and completion of all associated documentation. The successful candidate will join a well-established team of analysts and Senior analysts and full training will be provided, with regular one to one coaching and support, to ensure you are able to fulfil the duties of the role.
Main Activities / Tasks
The role will involve:
- Endotoxin Testing
- Biological Challenge verification and preparation
- Participation in Media Fill Simulation Trials
- Perform thermal mapping of autoclaves, depyrogenation tunnels and fixed tanks and pipework using thermocouple base data acquisition systems.
- Interpretation and evaluation of thermal mapping data.
- Preparation of Validation Protocols, Validation Reports, Validation Master Plan and SOPs.
- Third level qualification in a science related discipline or a minimum of 12 months relevant industry experience in a Production or laboratory setting and A-level(s) in a science related subject.
- The successful candidate should have an understanding of, or at a minimum be familiar with, the use of a biological challenge and thermal mapping to demonstrate process sterility.
- Applicants should be able to demonstrate good knowledge of current Good Manufacturing Practices (cGMP)..
- Excellent written and oral communication skills as demonstrated in the application form and at interview.
- Have a ‘Hands On’ approach to working within a fast paced work environment.
- Proven ability to organise, plan and prioritize multiple concurrent tasks whilst maintaining a high level of accuracy in all work produced along with a proven ability to meet deadlines.
- Laboratory experience as part of studies and if possible an understanding of current Good Laboratory Practices (cGLP).
- Experience in Microbiological Identification Techniques and Aseptic Processing Operations.
- Operating knowledge of a thermocouple based data acquisition system is an advantage but not essential.
- Experience of cleanroom operation.