PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience.
SUMMARY
The Computer System Validation (CSV) Specialist is responsible for ensuring that PROCEPT computer systems and software to comply with regulatory requirements and industry standards. This is a crucial role in validating and documenting the functionality, security, and compliance of these systems. The Computer System Validation Specialist is responsible for planning, executing, and documenting the validation processes for computer systems and software applications ,and ensure that these systems meet regulatory and quality standards while maintaining data integrity and security.
CORE RESPONSIBILITIES
- Validation Planning:
- Develop validation protocols, plans, and strategies for computer systems in compliance with FDA 21 CFR Part 11 standard.
- Documentation and Traceability:
- Create, review, and maintain validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), and Validation Plans.
- Ensure traceability of requirements throughout the validation process.
- Testing and Execution:
- Execute validation tests, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct risk assessments to identify in-scope/out-of-scope systems and applications, based on critical system functions and potential vulnerabilities.
- Change Control:
- Implement and manage change control processes to assess and approve system changes, including software updates and configuration modifications.
- Data Integrity and Security:
- Validate data integrity measures, including audit trails, electronic signatures, and access controls.
- Ensure systems are compliant with security standards and policies.
- Compliance Assurance:
- Ensure that computer systems adhere to regulatory GxP standard.
- Documentation and Reporting
- Maintain comprehensive validation records and generate validation summary reports.
- Communicate validation status and findings to stakeholders and regulatory agencies as necessary.
- Training and Support:
- Provide training and guidance to end-users and staff on validated systems and processes.
- Offer technical support for system-related issues during and after validation.
- Vendor Interaction:
- Collaborate with software vendors and suppliers to ensure validation documentation and compliance.
- Evaluate vendor-provided documentation for accuracy and completeness.
QUALIFICATIONS (Education, Experience, Certifications)
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree in a related field, such as Computer Science, Information Technology, or Life Sciences.- preferred
- Knowledge of regulatory requirements, including FDA regulations (21 CFR Part 11) and GxP compliance.
- At least 3 years of experience in computer system validation, preferably in the pharmaceutical or medical device industry.
- Familiarity with validation methodologies and tools.
- Strong understanding of software development lifecycles and quality assurance.
- Excellent documentation and technical writing skills.
- Attention to detail and strong problem-solving abilities.
- Knowledge of data integrity, security, and electronic records management.
- Ability to work both independently and collaboratively within cross-functional teams.
PHYSICAL DEMANDS & WORK ENVIRONMENT
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds.
- This role is expected to be a hybrid role with in-office work expected 2 to 3 times per week.
For US Based Candidates Only
For this role, the anticipated base pay range is $85,000-$121,000 a year.
PROCEPT BioRobotics is committed to fair and equitable compensation practices and we aim to provide employees with total compensation packages that are market competitive. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate’s qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. PROCEPT also offers a comprehensive suite of benefits including, but not limited to, health insurance plans, ESPP, 401k retirement savings plan with a company match, and paid time off programs. All compensation and benefits programs are subject to the discretion of the company.