IT Computer System Validation Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

This position's primary role is to work closely with the internal IT teams and cross-functional departments (Business & PQ-CSV) to support computer system validation activities related to projects and change requests.

Essential Job Duties

• Responsible for oversight of all GxP-regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV), and Lifecycle procedures with Data Integrity requirements.
• Provide oversight of validation activities, lead the development and approval of validation documentation and risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessment of proposed changes to computerized systems.
• Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820, 21 CFR Part 11, Annex 11, and Data Integrity.
• Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Intuitive Surgical policies and procedures.
• Coordinate and provide training and/or opportunities for career development of others.
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts, reporting metrics, and communicating internally to diverse audiences.
• Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments, and Validation Summary Reports.
• Analyze business processes to translate development documents into user requirements and functional design specifications.
• Establish validation standards, develop testing protocols, document test results, and maintain records for later analysis.
• Documentation and remediation of deviations resulting from validations/qualifications.
• Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
• Author/Update assigned Operating Procedures (SOPs & DOPs), Policies, and validation templates to ensure compliance with Company policies and federal regulations.
• Support regulatory agency inspections/audits, as required.
• Must be familiar with cGMPs and current industry guidelines.
• Interfaces between various internal and external functional areas to ensure successful integration and completion of validation activities in overall project schedules.
• Applies quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution, and completion.
• Maintains awareness of regulatory requirements.

Qualifications

Required Skills and Experience

• Minimum Bachelor’s degree (B.S.) in related field or equivalent.
• At least 3 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) focusing on GxP systems.
• Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 13485:2003, and ISO 9001 Standards.
• Strong knowledge of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
• Understanding of the FDA’s recent guidance on the transition of CSV to CSA.
• Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
• Ability to work on complex projects with general direction and minimal guidance.
• Ability to handle multiple projects and meet deadlines.
• Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

Required Education and Training

• Minimum Bachelor’s degree (B.S.) in related field or equivalent.

Working Conditions

• Set schedule

Preferred Skills and Experience

• Hands-on experience with Microsoft Word, Excel, PowerPoint & Visio.
• Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.