Location: Onsite in bay area
Duration: 3 months
Hours per week: 40
Start Date: ASAP
Job Description:
Our client is looking for an experienced validation engineer who can help generate the cycle development, performance qualification, and summary reports for a new autoclave. The client installed the autoclave last year and has completed the SAT and FAT as well as vendor and client IOQ. They need someone who is familiar with autoclaves who can generate the cycle development protocol. They currently have an older autoclave on its last leg and could potentially develop off of the current cycle but this is a newer and different brand.
The client has 3 separate cycles they need to generate protocols for. Their wrapped goods cycle is the most commonly used one, then one for liquid and one for carboy. They may take a phased approach and start with the wrapped goods and go onto the other cycles after. This resource will need to write the protocols and then help with the execution. If the run is successful a summary report will then need to be generated. After the cycle development protocols are finished, they will need to generate and execute the performance qualification as well. There are manufacturing associates to support but otherwise this person needs to be a driver.
Skills: Sterilization cycles with autoclaves
Biological Indicators – MUST
Plus: Steris Autoclave experience
Experience: 7-8 years is the sweet spot. Needs a do-er, not someone to wait for orders or try and focus on other things.
Autoclave Validation Consultant (233170) CA