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.