We are looking for multiple CQV Engineers to support our LA area clients project.
We are looking for 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 protocols final reports.
Responsibilities:
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.
Installation Qualification.
Equipment installation verification and confirmation that the equipment is installed in accordance with the manufacturers specifications.
Document equipment installation and location.
Operational Qualification.
Equipment functional verifications under operational conditions.
Conduct testing of equipment functionality and performance.
Documenting of all test results and deviations.
Performance Qualification.
Confirmation of the fractionation performance.
Validate the manufacturing process and critical process parameters.
Generate and review batch records and documentation.
Process Validation.
Conduct process validation studies to ensure consistent product quality.
Perform risk assessments and implement process controls.
Develop and validate analytical methods for product testing.
Cleaning Validation.
Validate the cleaning procedures for the equipment to prevent cross-contamination.
Document cleaning validation protocols and results.
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