Role: Validation Engineer/Analyst
Location: Seattle, WA
Duration: 6-12 Months+
Interview: 2 rounds Skype
Rate: $55-70/hr on C2C DOE
Visa: All except OPT/CPT 
 
 
Need below document:
  • Visa (EAD or GC or H1B) copy : Mandatory
  • DL copy : Mandatory
  • Passport Number : Mandatory
  • LinkedIn profile: Optional
  • Last 2 references : Optional but should able to provide upton request
 

Experience Range

7-11 Yrs.

Job Title:

Validation Specialist

Primary Skill Set

Validation planning, Review of Validation deliverables, Defect Management, Periodic Reviews.

Secondary Skill Set

N/A

Roles and Responsibilities

o   Understanding of the purpose of validation.

o   Understanding of the overall validation approach for a project.

o   Understanding of IT processes and the lifecycle of IT systems.

o   Advanced knowledge of all IT process interactions.

o   Advanced knowledge of information technology areas and IT service principles.

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

o   Strong working knowledge of good documentation practices.

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

o   Knowledge of computer network and system security principles.

o   Knowledge of IT infrastructure principles.

o   Experience in Validation functions in regulated or controlled environments.

o   Experience in IT QA functions in regulated or controlled environments.

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

o   Experience in the creation and execution of infrastructure qualification strategies.

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

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

o   Experience working with controlled documentation systems.

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

 

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