Senior Computer System Validation Engineer

PROCEPT BioRobotics•San Jose, CA

12h

About The Position

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. The Opportunity That Awaits You: The Senior Computer System Validation Engineer will lead and support the Computer System Validation (CSV) process within PROCEPT BioRobotics’ Quality System. This individual will enhance, implement and maintain CSV strategy, Policies, Standard Operating Procedures, Work Instructions, and templates for CSV and data integrity to ensure compliance with global regulatory requirements. This individual must have a strong CSV background and the ability to work cross functionally with all departments to assess validation needs for all non-product computer software systems. What Your Day-To-Day Will Involve: 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

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