Responsible for all computerized systems in regulated industries comply with stringent regulatory requirements by validating their functionality, security, and data integrity. The role includes creating validation plans, conducting testing, writing detailed validation documentation, managing deviations, ensuring regulatory compliance, and providing ongoing support for systems. A CSV Specialist must have a strong understanding of both IT systems and regulatory guidelines, as well as excellent documentation, communication, and project management skills. The position is essential in maintaining the integrity of systems that handle critical data, ensuring that organizations meet legal and quality standards.
KEY RESPONSIBILITIES:1.Ensure all systems performs consistently as intended and that the data it generates, processes, and stores remains accurate, complete, and reliable over its lifecycle.
2.Create and manage the computer system validation strategy and approach, ensuring it aligns with industry regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, GxP). This includes defining the scope, objectives, and approach for each validation project.
3.Work with stakeholders to gather and document user requirements for the system, ensuring they reflect the business needs and regulatory requirements.
4.Prepare and manage key validation documents, including Validation Master Plans (VMP), risk assessments, protocols, test plans, and reports. Ensure that these documents are compliant with internal and external standards.
5.Design, document, and execute detailed test cases that demonstrate that the system meets the validation requirements. This includes functional testing, integration testing, and user acceptance testing (UAT)
6.Ensure that data integrity is maintained throughout the lifecycle of the system, from data entry to storage and retrieval, ensuring compliance with regulatory standards.
7.Assess the risk associated with the computer system's use, focusing on data integrity, security, and compliance. Apply risk-based approaches to prioritize validation efforts and testing.
8.Propose risk mitigation strategies for identified issues or potential failures, and ensure they are integrated into the validation and quality processes.
9.Follow change control procedures for any changes made to validated systems, ensuring that the system is re-validated after modifications to maintain compliance and data integrity.
•A bachelor’s degree in a relevant field such as Computer Science, Life Sciences, Engineering, or a related discipline.
•Experience with GxP regulations (Good Manufacturing Practices, Good Laboratory Practices) and 21 CFR Part 11 (FDA’s requirements for electronic records and signatures) is highly desirable
•Familiarity with software development life cycle (SDLC) methodologies (e.g., Waterfall, Agile) and experience working with different system types such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), or Enterprise Resource Planning (ERP) systems
•3-7 years of Quality / relevant process experience
•Ability to lead and manage a team
•Ability to succeed in environment with conflicting priorities.
Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:
Flexible workHealthcare including dental, vision, mental health, and well-being programsFinancial well-being programs such as 401(k) and Employee Share Ownership PlanPaid time off and paid holidaysPaid parental leaveFamily building benefits like adoption assistance, surrogacy, and cryopreservationSocial well-being benefits like subsidized back-up child/elder care and tutoringMentoring, coaching and learning programsEmployee Resource GroupsDisaster ReliefAbout Capgemini EngineeringWorld leader in engineering and RD services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure Transportation, Energy, Utilities Chemicals, Life Sciences, Communications, Semiconductor Electronics, Industrial Consumer, Software Internet.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.
Get the Future You Want|www.capgemini.com
DisclaimerCapgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.
Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.
Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.
Job description:Responsible for all computerized systems in regulated industries comply with stringent regulatory requirements by validating their functionality, security, and data integrity. The role includes creating validation plans, conducting testing, writing detailed validation documentation, managing deviations, ensuring regulatory compliance, and providing ongoing support for systems. A CSV Specialist must have a strong understanding of both IT systems and regulatory guidelines, as well as excellent documentation, communication, and project management skills. The position is essential in maintaining the integrity of systems that handle critical data, ensuring that organizations meet legal and quality standards.
KEY RESPONSIBILITIES:1.Ensure all systems performs consistently as intended and that the data it generates, processes, and stores remains accurate, complete, and reliable over its lifecycle.
2.Create and manage the computer system validation strategy and approach, ensuring it aligns with industry regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, GxP). This includes defining the scope, objectives, and approach for each validation project.
3.Work with stakeholders to gather and document user requirements for the system, ensuring they reflect the business needs and regulatory requirements.
4.Prepare and manage key validation documents, including Validation Master Plans (VMP), risk assessments, protocols, test plans, and reports. Ensure that these documents are compliant with internal and external standards.
5.Design, document, and execute detailed test cases that demonstrate that the system meets the validation requirements. This includes functional testing, integration testing, and user acceptance testing (UAT)
6.Ensure that data integrity is maintained throughout the lifecycle of the system, from data entry to storage and retrieval, ensuring compliance with regulatory standards.
7.Assess the risk associated with the computer system's use, focusing on data integrity, security, and compliance. Apply risk-based approaches to prioritize validation efforts and testing.
8.Propose risk mitigation strategies for identified issues or potential failures, and ensure they are integrated into the validation and quality processes.
9.Follow change control procedures for any changes made to validated systems, ensuring that the system is re-validated after modifications to maintain compliance and data integrity.
•A bachelor’s degree in a relevant field such as Computer Science, Life Sciences, Engineering, or a related discipline.
•Experience with GxP regulations (Good Manufacturing Practices, Good Laboratory Practices) and 21 CFR Part 11 (FDA’s requirements for electronic records and signatures) is highly desirable
•Familiarity with software development life cycle (SDLC) methodologies (e.g., Waterfall, Agile) and experience working with different system types such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), or Enterprise Resource Planning (ERP) systems
•3-7 years of Quality / relevant process experience
•Ability to lead and manage a team
•Ability to succeed in environment with conflicting priorities.
Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:
Flexible workHealthcare including dental, vision, mental health, and well-being programsFinancial well-being programs such as 401(k) and Employee Share Ownership PlanPaid time off and paid holidaysPaid parental leaveFamily building benefits like adoption assistance, surrogacy, and cryopreservationSocial well-being benefits like subsidized back-up child/elder care and tutoringMentoring, coaching and learning programsEmployee Resource GroupsDisaster ReliefAbout Capgemini EngineeringWorld leader in engineering and RD services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure Transportation, Energy, Utilities Chemicals, Life Sciences, Communications, Semiconductor Electronics, Industrial Consumer, Software Internet.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.
Get the Future You Want|www.capgemini.com
DisclaimerCapgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.
Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.
Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.