Validation Engineer - GxP Systems

San Francisco, CA, US • Posted 60+ days ago • Updated 4 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Management
  • Computerized System Validation
  • GxP
  • Documentation
  • Regulatory Compliance
  • ISO 13485
  • Quality Assurance
  • Manufacturing
  • Change Control
  • Auditing
  • Corrective And Preventive Action
  • Document Management
  • Mentorship
  • Data Integrity
  • Computer Science
  • Life Sciences
  • Medical Devices
  • Verification And Validation
  • Cloud Computing
  • SaaS
  • Microsoft Office
  • Jama
  • Communication
  • Collaboration
  • Teamwork
  • GAMP
  • PMP

Summary

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.
Requirements:
  • 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.
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: 91116760
  • Position Id: 61a2f7f94dab475d2580b1a510f5685b
  • Posted 30+ days ago
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