Validation Engineer Job at I3 INFOTEK INC, Clayton, NC

MEZlT3JleWlvT2ltQitwNFpFQnNRZDhMclE9PQ==
  • I3 INFOTEK INC
  • Clayton, NC

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.

Job Tags

Similar Jobs

Spectrum Plastics Group, A DuPont Business

Environment, Health and Safety Manager Job at Spectrum Plastics Group, A DuPont Business

Job Description: The EHS Manager (Multi-Site) will coordinate and oversee the companys environmental health, and safety program in accordance with company, state, and federal requirements, as well as act as a catalyst for the growth and development of ESG initiatives...

HDI Global SE

Executive Underwriter, Energy Job at HDI Global SE

 ...We are currently seeking a seasoned Executive Underwriter, Energy to join our team, focusing on underwriting complex energy risks...  ...manage a portfolio of complex energy accounts, including both renewable and traditional energy risks. Develop and maintain strong relationships... 

Vertex Hospitality Group

Director of Supply Chain (Food Industry) Job at Vertex Hospitality Group

 ...Distribution Manage logistics operations, including transportation, warehousing, and distribution, to ensure on-time delivery and fulfillment of orders. Evaluate and optimize transportation routes, modes, and carriers to reduce shipping costs and improve delivery... 

The Crox Group

Building Maintenance Technician Job at The Crox Group

 ...JOB DESCRIPTION Maintenance Technician Basic Responsibilities: The Maintenance Technician reports to the Maintenance Property Manager...  ...service requests. Responsible for the daily upkeep of the grounds and common areas of your property, including trash, pet waste,... 

Hanwha Philly Shipyard

Security Officers - Transportation Facility Job at Hanwha Philly Shipyard

 ...government contracts, such as the National Security Multi-Mission Vessels (NSMVs) for the U....  ...and abilities required to stand up and manage a compliant and mission-ready security...  ...compliance with all applicable federal, DoD, and corporate requirements. Year One Critical...