Computer System Validation Specialist

4 weeks ago


Muskegon, United States Medix Full time

Position Summary

The Computer Validation Coordinator (CVC) will play a pivotal role in orchestrating validation initiatives for computer systems, both hardware and software, with a particular focus on laboratory environments, ensuring the integrity of processes. Responsibilities of the CVC include overseeing the progress of computer validation projects, crafting planning documents for computer systems, and devising testing protocols. Additionally, this role entails scrutinizing test outcomes, pinpointing areas for enhancement, and effectuating necessary adjustments. The CVC will also lend technical expertise to colleagues and other departments, articulating validation strategies and formulating protocols. Ensuring compliance with GxP, GAMP, and Code of Federal Regulations standards for systems and processes is a paramount responsibility.

Position Responsibilities

  • Collaborate with QA management to devise and implement an effective software/computer validation framework tailored to GLP environments.
  • Identify validation requisites for computerized systems via internal evaluations or by coordinating external needs assessments.
  • Collaborate with business and validation teams on site-specific computer validation ventures.
  • Draft software/computer validation protocols and compile final reports, overseeing activities according to protocols.
  • Manage the Master Validation Schedule for the site and conduct periodic assessments of validated systems.
  • Support QA in auditing vendors of cGMP-related software and hardware.
  • Evaluate vendor validations, supplementing with company-specific protocols as necessary to ensure thorough validation.
  • Offer technical guidance on validation plans and protocol designs, contributing to the formulation of equipment, facility, and systems specifications.
  • Conduct SOP training for company personnel as required.
  • Perform other duties as assigned.

Position Requirements

  • Minimum: Bachelor's degree or equivalent.
  • Experience: 5-10 years in Computer System Validations.
  • Proficiency in GxP standards.
  • Competency level required for role as determined by departmental training guidelines.
  • Familiarity with GLPs (21 CFR Part 11) and other pertinent federal IT regulations.
  • Advanced comprehension of laboratory operations and data management.
  • Ability to thrive in high-pressure environments with tight deadlines.


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