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Validation Engineer GxP Systems
Staftonic LLCFremont, CA, US4 days ago
Job type
- Part-time
Job descriptionBachelors 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.
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 :
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Validation Engineer • Fremont, CA, US
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