Katalyst Healthcares and Life Sciences
Validation Engineer
Katalyst Healthcares and Life Sciences, Rensselaer, New York, United States, 12144
Responsibilities:
Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.). Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems. uthor validation life cycle documents for client's review and approval. Route drafted documents for review. Route reviewed documents for workflow approval. Request approval workflows to Doc Control. Execute approved protocols in GxP facility. Understand SDLC process and SDLC methodology such as agile etc. Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables. Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area. uthor change control documents for client review and approval. Requirements:
Prior experience with benchtop instrument experience is a must. Bachelor's/ master's degree or equivalent in a scientific or health care field. 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.
Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.). Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems. uthor validation life cycle documents for client's review and approval. Route drafted documents for review. Route reviewed documents for workflow approval. Request approval workflows to Doc Control. Execute approved protocols in GxP facility. Understand SDLC process and SDLC methodology such as agile etc. Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables. Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area. uthor change control documents for client review and approval. Requirements:
Prior experience with benchtop instrument experience is a must. Bachelor's/ master's degree or equivalent in a scientific or health care field. 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.