Description
A leading Medical Technology company are currently looking for an experienced CSV Engineer to work at their biopharmaceutical site based in the UK.The company are preparing for an FDA audit and as part of this preparation they have performed some GAP analysis on aspects of their validation plan.
An area of weakness that has been identified is within the CSV (Computer Systems Validation) area.
They therefore require an experienced engineer who is able to review existing documents (perform remediation) and put together fixes. They will be required to both write protocols - mainly IQ/PQ - and where necessary perform execution.
The systems they will be involved in will range from simple spread sheets through to SCADA systems, controlling a variety of equipment such as Lab, Clean room and Manufacturing.
Experience and Skills required:
-Ideally Degree qualified
-Extensive full lifecycle validations within CSV
-Experience in working within a biopharmaceutical manufacture facility
-Familiar with current FDA and European cGMP regulations
-Experience of updated Validation Master Plans
-Experience working on the IT Systems/Computer Systems: Laboratory, Manufacturing, Packaging, SCADA
-Strong experience with CFR21 Prt11