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This range is provided by VTI Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
$100,000.00/yr - $150,000.00/yr
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VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.
We are looking for multiple CQV Engineers to support our LA area client's project. We need CQV Engineers with CQV experience to provide execution support (IQ, OQ, PQ) for systems and equipment including process vessels, buffer vessels, filter presses, centrifuges, CIP skids, clean rooms, WFI, RO storage tank, cold and chilled alcohol loops, compressed air, nitrogen distribution, process transfer line and pool tank piping.
You must have experience in executing CQV protocols within pharmaceutical facilities and have written and executed protocols and protocol final reports.
Responsibilities include but are not limited to the following:
Provide validation support (IQ, OQ, PQ) for process vessels, buffer vessels, filter presses, centrifuges, CIP skids, clean rooms, WFI, RO storage tank, cold and chilled alcohol loops, compressed air, nitrogen distribution, process transfer line and pool tank piping.
o Equipment installation verification and confirmation that the equipment is installed in accordance with the manufacturer's specifications
o Document equipment installation and location. Operational Qualification
o Equipment functional verifications under operational conditions.
o Conduct testing of equipment functionality and performance.
o Documenting of all test results and deviations
Performance Qualification
o Confirmation of the fractionation performance o Validate the manufacturing process and critical process parameters.
o Generate and review batch records and documentation.
Process Validation
o Conduct process validation studies to ensure consistent product quality.
o Perform risk assessments and implement process controls.
o Develop and validate analytical methods for product testing.
Cleaning Validation
o Validate the cleaning procedures for the equipment to prevent cross-contamination.
o Document cleaning validation protocols and results
Facility Qualification
o Conduct validation of critical facility systems
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