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Computer Validation Engineer

Company Name:
Career Development Partners
Validating computerized systems and software applications by preparing and executing installation, operation, and performance qualification protocols;
Gathering and summarizing protocol data, preparing interim and final reports for management review and approval;
Creating, revising and updating control system SOPs;
Supporting and participating in computer system updates and repairs;
Ensuring that backup and archive copies of computer programs are maintained in secure storage for all validated systems;
Maintaining a thorough understanding of regulatory requirements and industry standards for computerized system validation and life cycle processes.

EDUCATION: 4-year degree is required; Computer Science or Electrical Engineering preferred.


REQUIRED SKILLS:
One or more years of computer experience, or recent graduate in Computer Science or Electrical Engineering;
Knowledge and understanding of computerized system validation as required by current GMPs and EU Annex 11, and the requirements for the use of electronic records and signatures;
Understands V-model for computerized system qualification, and the computerized system life cycle processes in GAMP5 guide;
Understands programmable logic controllers, ladder logic software, and operator interface terminals, and Windows OS and networks.


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