Computer System Validation Engineer Job at Technoviz LLC, Madison, WI

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  • Technoviz LLC
  • Madison, WI

Job Description

Job Description

Job Description

Benefits:

  • Competitive salary
  • Opportunity for advancement
  • Training & development
Job Summary
We are seeking a skilled System Validation Engineer to join our team! As a System Validation Engineer, you will be responsible for
validating documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) and responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.

Responsibilities
  • Validate GMP Lab systems and Equipment
  • Identify and escalate, as necessary project risks and issues to the CSVC Manager
  • Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs
  • Be able to prepare reports on defects and problems that arise during system testing
  • Have solid oral and written communication skills and teamwork skills
  • Work with business representatives to ensure the test cases reflect business rules and processes
  • Fulfills the role of a subject matter expert role for critical quality and compliance GxP end-use applications supporting Animal Health business processes
  • Work with business representatives to ensure the test cases reflect business rules and processes
  • Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.
Qualifications
  • Be a good team player, able to meet deadlines and handle changing priorities
  • Have strong judgment capabilities to clarify requirements when necessary
  • Have the ability to work with cross functional teams
  • Have solid experience working with validated systems
  • GMP/Regulated lab, more than 5 years of CSV experience required
  • Technical writing Experience
  • Highly skilled in Computerized System testing and validation in the healthcare industry
  • Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)
  • Solid project organizational skills and ability to multi-task with strong analytical problem-solving skills
  • Excellent communication including written, verbal, and listening skills
  • Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision
  • BS in Science or Technical Writing Degree

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