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Sr. Computer System Validation Engineer

System One Holdings, LLC
Saint Joseph, MO Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/29/2025

Job Title : Sr. Computer System Validation Engineer

Location : St, Joseph, MO

Type : Contract

Responsibilities

  • Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports)
  • Experience in validating GMP Lab systems and Equipment
  • 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.
  • 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.
  • 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.
  • 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.

Requirements

  • 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. Ability to multi-task.
  • Must have 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
  • Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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