Validation Engineer - GxP Systems - Katalyst Healthcares and Lifesciences - San Francisco, CA, US | Dice.com

Katalyst Healthcares and Lifesciences

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Validation Engineer - GxP Systems

San Francisco, CA, US • Posted 6 hours ago • Updated 6 hours ago

Full Time

On-site

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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 6 hours ago

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Validation Engineer - GxP Systems

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