Description
An excellent new full time permanent opportunity has arisen within a Biotech organisation for 2 Validation Specialists. Our client manufactures a wide range of plasma products and are committed to research and development to maintain a key position in a constantly changing market in the 21st century. They operate as a business with commercial objectives and disciplines and compete in both the UK and over 45 international markets.Job Description:
•Routine Validation / Remediation Validation / Project Validation activities to include:
- Cleaning validation
- Mixing validation
- Equipment validation (chromatography, tanks etc)
- Sterilisation (SIP, VHP)
•Creation and review documents for qualification and validation (e.g. qualification plans / reports, validation plans / reports, risk analysis, work instructions).
•Review of supplier qualification documents.
•Monitoring / participation in the implementation of the FAT/SAT and qualification/validation measures, to work together with suppliers and operation personnel.
Minimum Requirements:
•Degree in Science or Engineering
•Experience of the following validation: Cleaning validation, mixing validation, equipment validation, sterilisation) with a diverse compliance background in cGMP manufacturing
•In depth knowledge of GMP / FDA regulations
•Previous experience of working in a pharmaceutical or biotech manufacturing environment
This campus is due for significant investment over the coming years due to recent acquisition. Therefore, this is a fantastic time to join a growing validation team with a varied workload; offering a competitive salary, in prime location with career growth opportunities.
Please apply now for more information.