PROCEPT BioRobotics

Senior Computer System Validation Engineer

PROCEPT BioRobotics

full-time

Posted on:

Location Type: Hybrid

Location: San Jose • California • United States

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Salary

💰 $120,000 - $142,000 per year

Job Level

Senior

About the role

  • 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

Requirements

  • 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
  • comprehensive benefits package
  • full medical coverage
  • wellness programs
  • on-site gym
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GxP compliancecomputer system validationvalidation documentationrisk assessmentsvalidation master planssystem requirements specificationsconfiguration specificationsIQ/OQ/PQ protocolsdata integrity principlessystem implementation models
Soft Skills
communicationorganizationleadershipcross-functional collaborationattention to detailadaptabilityproject managementtrainingproblem-solvingchange management