Job Description

Title: Validation Engineer

Location: Clayton, NC fully onsite

Experience: 4+ years

Below is the job description:

• 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.
• Author 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
• Author change control documents for client review and approval

Qualifications:

• Prior experience with benchtop instrument experience is a must
• Bachelor’s/ Master’s degree or equivalent in a scientific or health care field.
• 5+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.

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