PROCEPT BioRobotics · 18 hours ago
Senior Computer System Validation Engineer
San Jose, CA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $142K/yr
5+ years expPROCEPT BioRobotics is dedicated to revolutionizing treatment for benign prostatic hyperplasia through innovative surgical robotics. The Senior Computer System Validation Engineer will lead the Computer System Validation (CSV) process, ensuring compliance with global regulatory requirements and enhancing the CSV strategy within the company's Quality System.
Health CareManufacturingMedical DeviceRobotics
No H1B
U.S. Citizen Only
Responsibilities
Act as the Subject Matter Expert and advise and support business and system owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards
Assess all new non-product computer software systems and spreadsheets to determine if they are for GxP usage
Manage the implementation of validation requirements for new and existing GxP computer systems and spreadsheets
Create and maintain Validation Master Plans (VMPs), project-specific validation plans and schedules
Ensure proper documentation and execution of:
System Requirements (URS & FRS)
Configuration & Design Specifications (CS/DS)
Risk Assessments
IQ/OQ/PQ Protocols and Reports
Traceability Matrices
Assessments
Drive change control for validated systems, ensuring ongoing compliance
Lead periodic reviews and oversee system decommissioning in compliance with regulatory requirements
Identify and ensure that all computerized systems at Procept are validated and remain in a compliant state
Partner with IT, Quality, Clinical, Commercial, Regulatory Affairs, Manufacturing, and R&D etc to ensure systems compliance
Stay updated with evolving FDA, EMA, ISO, and global regulatory guidance on computer system validation and data integrity
Act as CSV Subject Matter Expert (SME) during internal audits, and regulatory inspections
Train Quality and cross-functional staff on CSV requirements, data integrity, and regulatory expectations
Assist in training users on new and modified system configurations, highlighting the impact on business processes
Drive continuous improvement in Quality Systems and CSV processes to align with GAMP 5 and evolving regulations
Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
Understand and adhere to the PROCEPT BioRobotics Quality & EHS policies
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
Minimum of 5+ years within medical device, biotech, or pharmaceutical industry
Strong understanding of 21 CFR Part 11, EU Annex 11, ISO 13485, GAMP 5, and data integrity principles
Experience in FDA, EU and cGxP regulations
Proven ability to prepare and review validation documentation to regulatory standards
Knowledge of system implementation models, computer system validation methodologies in regulated environments
Understanding of modern and risk-based validation executions
Hands-on experience with supporting systems integration and validation of Enterprise Systems, Product Lifecycle Management Software, etc
Experience supporting audits and regulatory inspections as CSV or Quality Systems SME
Strong documentation, organization, communication, cross-functional collaboration and leadership skills
Ability to work on multiple projects concurrently and effectively adapt to changing priorities
Ability to work with minimal supervision or guidance
Excellent attention to detail
Must have superb organizational skills and the ability to execute within strict timelines
Benefits
Full medical coverage
Wellness programs
On-site gym
A 401(k) plan with employer match
Short-term and long-term disability coverage
Basic life insurance
Wellbeing benefits
Flexible or paid time off
Paid parental leave
Paid holidays
Company
PROCEPT BioRobotics
PROCEPT BioRobotics is a surgical robotics company that develops water-based robotic systems for prostate surgery.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$820.34MKey Investors
CIBC Innovation BankingFidelityViking Global Investors
2024-10-29Post Ipo Secondary· $175M
2023-08-01Post Ipo Equity· $150M
2022-10-10Post Ipo Debt· $52M
Leadership Team
Mohan F. Sancheti
Vice President Operations
Recent News
thefly.com
2025-12-09
2025-11-07
PROCEPT BioRobotics
2025-11-05
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