Company Overview
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
The Qualifications We Need You to Possess
- 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
For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role, the anticipated base pay range is $120,000-1142,000 per year
Plus, eligibility for an annual bonus and equity/RSUs
Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.
An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
BENEFITS OF WORKING AT PROCEPT!
PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes 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, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.
PAY RANGE TRANSPARENCY
Procept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.
WORK ENVIRONMENT
We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
PROCEPT BioRobotics – Applicant Privacy Notice
When you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, résumé or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role.
To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy]. 