Katalyst CRO · 2 months ago
Validation Engineer – GxP Systems
San Francisco Bay Area, CA
Full-time
Onsite
Senior Level
6+ years expKatalyst CRO is a confidential company seeking a Validation Engineer for GxP systems. The role involves leading and managing computer system validation across various areas, ensuring compliance, and mentoring junior team members.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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