Ecocareers · 2 months ago
Validation Engineer – GxP Systems
San Francisco Bay Area, CA
Full-time
Onsite
Senior Level
6+ years expConfidential company is seeking a Validation Engineer specializing in GxP Systems. The role involves leading and managing Computer System Validation across various sectors, ensuring compliance with industry standards, and mentoring junior team members.
Staffing & Recruiting
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
Qualification
Required
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
GAMP Practitioner
PMP
ASQ-CQA
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase