Pharmaceutical IT Validation Expert

2 days ago


Austin, Texas, United States Azzur Group Full time

We are seeking a highly skilled Pharmaceutical IT Validation Expert to join our team at Azzur Group.

About the Job:

This role involves performing hands-on testing and creating validation testing scripts to confirm system functionality.

Responsibilities:

  • Develop and execute validation documentation, including protocols and reports, for computerized systems in compliance with industry regulations.
  • Collaborate with cross-functional teams to assess system requirements and ensure they meet GxP, GDP, GAMP, and 21 CFR Part 11 standards.
  • Conduct risk assessments and create strategies to mitigate potential non-compliance risks.
  • Maintain documentation integrity and manage change controls effectively.
  • Communicate project status, issues, and solutions to stakeholders professionally and clearly.

Requirements:

  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
  • A minimum of 5-8 years of experience in Computer Systems Validation (CSV) within the pharmaceutical, biotech, or healthcare industries.
  • Strong understanding of validation principles and regulatory requirements, including 21 CFR Part 11 and GxP.
  • Proficiency in writing and reviewing validation documentation.
  • Excellent analytical skills with a keen eye for detail.
  • Strong problem-solving abilities and effective communication skills.
  • Ability to work collaboratively in a team environment and manage multiple projects simultaneously.
  • Relevant certifications, such as Certified Software Quality Engineer (CSQE), are a plus.

The estimated salary for this position is $120,000 - $180,000 per year, depending on experience.

Azzur Group offers a comprehensive benefits package, including health insurance, retirement plans, and paid time off.



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