drjobs CSV Specialist – Windows 11 Upgrade

CSV Specialist – Windows 11 Upgrade

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1 Vacancy
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Job Location drjobs

Guayama - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico the United States Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

We are hiring a Validation Specialist to support Computer System Validation (CSV) activities during the Windows 11 migration. The role ensures compliance with FDA regulations and internal quality standards throughout the system lifecycle.

Responsibilities:

  • Prepare and execute validation deliverables (IQ/OQ/PQ Traceability Matrix Protocols).
  • Assess the impact of Windows 11 upgrade on existing validated systems.
  • Support change control and risk assessment documentation.
  • Collaborate with IT and QA teams to ensure alignment with regulatory guidelines.
  • Review and update SOPs and validation documentation as needed.

Requirements:

  • Bachelors degree in Life Sciences Engineering Computer Science or equivalent.
  • Minimum 3 years of experience in CSV within the pharmaceutical industry.
  • Knowledge of GAMP 5 21 CFR Part 11 and data integrity principles.
  • Experience validating OS upgrades or infrastructure changes is highly desirable.
  • Detail-oriented with strong technical writing and documentation skills


Required Experience:

Unclear Seniority

Employment Type

Full-Time

Company Industry

About Company

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