We have a very exciting new position available for a Commissioning, Qualification & Validation Engineer for a 6 month contract in Sandwich, Kent UK.
You will work for a market leading pharmaceutical company based at the Discovery Science Park as a consultant or freelancer. As is common with these contracts there is a chance of an extension after the initial 6 months.
Below, a list of the responsibilities the role entails and also the types of projects you might work on if successful.
* Validation of pharmaceutical and biotechnology facilities including HVAC, manufacturing equipment and clean utility systems. Computer system validation
* Writing and maintaining URS
* Writing and maintaining DQ, IQ, OQ, FAT and SAT protocols for manufacturing facilities & equipment
* Executing DQ, IQ, OQ, FAT and SAT protocols
* Generating documentation for and leading Detailed Design reviews and project Risk Register reviews
* Working to cGMP standards for MHRA and EU regulatory approval
* Review and approval of functional specifications, change controls and deviations as well as executed test documentation including IQ/OQ/PQ
* Environmental mapping of facilities
* Writing commissioning documents and commissioning of equipment
* Working with life cycle approach to validation
* Familiarity with GAMP and 21 CFR Part 11 Example Projects
* Validation of Testo environmental monitoring system
* Validation of facility to accommodate melt, spray, congeal equipment * Validation of facility to accommodate fluid bed dryer, granulator & coater
* Validation of Process Control System
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carbon60 is a trading name of Carbon60 Limited an Employment Business/Agency.