Validation Engineer – GxP SystemsKatalyst HealthCares & Life Sciences • San Francisco Bay Area, CA
Validation Engineer – GxP Systems
Katalyst HealthCares & Life Sciences • San Francisco Bay Area, CA
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job_description.job_card.job_descriptionBachelor's degree in engineering, Computer Science, IT, or Life Sciences. years of experience in medical device or regulated industry; + years in software validation. Strong knowledge of GAMP , Part , Annex , 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.
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 , CFR Part , and ISO .
- 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 :
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Validation Engineer • San Francisco Bay Area, CA
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