What are the responsibilities and job description for the Computer System Validation (CSV) Specialist position at capgemini?
The CSV (Computer System Validation) Specialist is responsible for ensuring that all computerized systems in regulated industries comply with stringent regulatory requirements. This includes validating functionality, security, and data integrity, creating validation plans, conducting testing, documenting results, managing deviations, ensuring regulatory compliance, and providing ongoing system support.
A CSV Specialist requires a strong understanding of IT systems and regulatory guidelines, as well as excellent documentation, communication, and project management skills. The role is critical in maintaining the integrity of systems that handle critical data, ensuring organizations meet legal and quality standards.
Key Responsibilities
- System Performance Assurance: Ensure all systems perform consistently as intended, maintaining accurate, complete, and reliable data throughout their lifecycle.
- Validation Strategy Development: Create and manage the computer system validation strategy and approach, ensuring alignment with industry regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, GxP). Define the scope, objectives, and methodology for each validation project.
- Requirement Gathering: Collaborate with stakeholders to gather and document user requirements, ensuring they address business needs and comply with regulatory standards.
- Validation Documentation: Prepare and manage critical validation documents, including Validation Master Plans (VMP), risk assessments, protocols, test plans, and reports. Ensure compliance with internal and external standards.
- Testing and Validation Execution: Design, document, and execute detailed test cases to demonstrate that systems meet validation requirements. This includes functional testing, integration testing, and user acceptance testing (UAT).
- Data Integrity Maintenance: Ensure data integrity throughout the system’s lifecycle, from data entry to storage and retrieval, in compliance with regulatory standards.
- Risk Assessment: Assess risks associated with system use, focusing on data integrity, security, and compliance. Apply risk-based approaches to prioritize validation and testing efforts.
- Risk Mitigation: Propose and integrate risk mitigation strategies for identified issues or potential failures into the validation and quality processes.
- Change Control: Follow change control procedures for any changes made to validated systems. Ensure re-validation after modifications to maintain compliance and data integrity.
Qualifications
- Education:
- Bachelor’s degree in a relevant field such as Computer Science, Life Sciences, Engineering, or a related discipline.
- Experience:
- 3–7 years of quality or relevant process experience.
- Direct experience with GxP regulations (Good Manufacturing Practices, Good Laboratory Practices) and FDA 21 CFR Part 11 (requirements for electronic records and signatures) is highly desirable.
- Skills:
- Familiarity with Software Development Life Cycle (SDLC) methodologies (e.g., Waterfall, Agile).
- Experience with various system types such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), or Enterprise Resource Planning (ERP) systems.
- Ability to lead and manage a team effectively.
- Strong problem-solving skills to succeed in environments with conflicting priorities.
The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
Salary : $25 - $40
