Validation Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title: Validation Engineer

Location: Seattle, WA

Duration: 12+ Months

Job Description:

8 plus Years of experience in Validation Engineer

Validation planning, Review of Validation deliverables, Defect Management, Periodic Reviews, LIMS system hands of experience

Participates in the planning, conduct, and evaluation of software testing for a complex enterprise-level business solution.

Must have experience on testing the Patient information integrated into a single system, decreasing the turnaround time for processing, releasing of tests and samples.

Experience on Validating the Reports for LIMS.

Understanding of the purpose of validation.

Understanding of the overall validation approach for a project.

Understanding of IT processes and the lifecycle of IT systems.

Advanced knowledge of all IT process interactions.

Advanced knowledge of information technology areas and IT service principles.

Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, EudraLex (such as Annex 11), PIC/S, including electronic records and electronic signatures.

Strong working knowledge of good documentation practices.

Familiarity with testing and defect management tools such as HP ALM.

Knowledge of computer network and system security principles.

Knowledge of IT infrastructure principles.

Experience in Validation functions in regulated or controlled environments.

Experience in IT QA functions in regulated or controlled environments.

Experience in the oversight of computer systems validation strategies and general IT quality assurance.

Experience in the creation and execution of infrastructure qualification strategies.

Experience with IT internal audit or periodic review, authoring audit reports or periodic review reports.

Ability to manage relationships with internal/external teams within the IT organization.

Experience working with controlled documentation systems.

Experience of working in an ITIL setting, knowledge of ITIL practices.