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Validation Engineer - GxP Systems

Validation Engineer - GxP Systems

Staftonic LLCSan Jose, CA, US
1 day ago
Job type
  • Full-time
Job description

Job Description

Job Title : Validation Engineer – GxP Systems

Location : San Francisco Bay Area

Long Term Project

Key Responsibilities :

  • Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas.
  • Develop and maintain validation procedures, templates, and master validation plans.
  • Prepare and review validation documentation (plans, protocols, reports).
  • Ensure compliance with GAMP 5, 21 CFR Part 11, and ISO 13485.
  • Collaborate with cross-functional teams (IT, QA, Engineering, Manufacturing, Clinical).
  • Support change control, audits, CAPA, and document control processes.
  • Mentor junior team members on data integrity and validation best practices.

Qualifications :

  • Bachelor’s degree in Engineering, Computer Science, IT, or Life Sciences.
  • 6+ years of experience in medical device or regulated industry; 3+ years in software validation.
  • Strong knowledge of GAMP 5, Part 11, Annex 11, and cloud / SaaS validation.
  • Proficiency in Microsoft Office, Google Suite, Jama, eQMS / ePLM.
  • Excellent communication and teamwork skills.
  • Preferred Certifications : GAMP Practitioner, PMP, ASQ-CQA.
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    Validation Engineer • San Jose, CA, US

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