Postat în: Ingineri în Leicester | Adăugat pe site: |
Validation Engineer
Leicester
£40,000 - £50,000 DOE
Permanent - Full-time (5 days a week, 37 hours)
SF require a 'hands-on' Validation Engineer to perform routine process validation and equipment qualification.
Validation is a Quality Assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements.
The position involves primarily preparing and executing validation/qualification protocols.
Equipment qualification and process validation will involve:
- Temperature controlled equipment
- Laboratory Balances
- Mixing Vessels
- Isolators
- Gas Generators
- Hot Air sterilising ovens
- Spray driers
- Sterilise-in-place systems
- HVAC/Facilities
- Computerised Systems
Working within a small team, your main duties will initially involve writing, executing and reporting validation protocols for a range of equipment. This will include temperature mapping of fridges, cold rooms, freezers, incubators and stability cabinets; using biological indicators to re-validate isolator gassing cycles; using biological indicators and endotoxin spiking to re-validate hot air ovens and sterilise in place systems.
You must have a very good understanding of Microsoft Word and Excel packages. The ability to write and format documents accurately with an eye for detail in reviewing documents is critical to the role. The ability to analyse and chart data in Excel is essential. Experience with Computerized Systems Validation and knowledge of ISPE's GAMP and FDA 21CFR Part 11 would be advantageous. Adherence to SOPs and experience with a QMS will be required.
The ideal candidate will have a life-science degree or similar with good communication, planning and organizational skills and be a strong problem solver. You must possess excellent multi-tasking skills with a proactive mindset to allow for efficient completion of activities. An understanding of Good Manufacturing Practice and background knowledge of clean rooms, sterility and equipment calibration is desirable