Computer Systems Validation Engineer

• Posted 9 hours ago • Updated 30 minutes ago
Full Time
Part Time
Fitment

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Job Details

Skills

  • IQ
  • OQ
  • PQ
  • GxP
  • ISO 9000
  • Documentation
  • Test Plans
  • Test Scripts
  • Regulatory Compliance
  • Pharmaceutics
  • Computerized System Validation
  • GAMP
  • SANS
  • SCADA

Summary

Role: Computer System Validation Engineer

(Hybrid- 3 days a week Onsite in San francisco CA) Bridgewater


Contract: 6 months with possible extension\

Minimum 10+ Years experience required .5 year in Pharma domain





Job Roles and Responsibilities:



* Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

* Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, and ISO regulations.

* Prepare and maintain detailed documentation for validation activities, including test plans, test scripts, and final validation reports.

* Document validation results clearly and consistently to ensure compliance with industry standards and regulations.

Requirements:

* Bachelors in any field (Preferably Computer, B.Pharma)

* Minimum 6 years of experience in Computer System Validation

* Must know GAMP5 (difference between Category3, 4 and 5).



Preferred: Experience with SCADA systems.


Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91003432
  • Position Id: OOJ - 7380-6439-1772823416
  • Posted 9 hours ago
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