What are the responsibilities and job description for the Computer Systems Validation Specialist position at Robert Half?
Job Details
Description
We are offering an exciting opportunity for a Computer Systems Validation Specialist in New Haven County, Connecticut. As part of our team, you will be instrumental in ensuring adherence of computer systems used in regulated industries to the requisite industry standards and regulatory requirements. This role involves a broad range of responsibilities, from the planning and execution to the documentation of validation activities for software systems.
Responsibilities
Develop validation plans, protocols, and summary reports for computer systems to ensure regulatory compliance and quality standards are met
Identify critical aspects of systems that impact product quality or patient safety through risk assessments and gap analyses, ensuring compliance with GxP regulations
Manage the entire System Development Life Cycle (SDLC) of computer systems, ensuring validation is integrated at each stage
Create and execute test protocols for system verification, documenting and resolving any discrepancies or deviations
Oversee system changes through a controlled change management process, ensuring that modifications maintain compliance with validation and regulatory requirements
Ensure validation activities are thoroughly documented, including user requirements, functional specifications, test cases, results, and validation reports
Serve as a subject matter expert during regulatory audits and inspections, providing validation documentation and explaining strategies and processes to auditors
Provide training to team members and stakeholders on validation requirements and best practices, while staying updated on regulatory changes and emerging industry trends.
Requirements
Minimum of 3 years of experience as a Computer Systems Validation Specialist or similar role.
Demonstrable knowledge and skills in GxP and GxP FDA.
Proficiency in handling Computer Systems and System Validation.
Experience in Compliance Risk management related to IT systems.
Familiarity with FDA 21 CFR regulations and guidelines.
Expertise in Software Validation is a must.
Comprehensive understanding and application of Validation Models.
Proven experience in Validation Testing.
Excellent communication and problem-solving skills.
Bachelor's degree in Computer Science, Information Technology, or related field is desirable.
Technology Doesn't Change the World, People Do.
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use.
We are offering an exciting opportunity for a Computer Systems Validation Specialist in New Haven County, Connecticut. As part of our team, you will be instrumental in ensuring adherence of computer systems used in regulated industries to the requisite industry standards and regulatory requirements. This role involves a broad range of responsibilities, from the planning and execution to the documentation of validation activities for software systems.
Responsibilities
Develop validation plans, protocols, and summary reports for computer systems to ensure regulatory compliance and quality standards are met
Identify critical aspects of systems that impact product quality or patient safety through risk assessments and gap analyses, ensuring compliance with GxP regulations
Manage the entire System Development Life Cycle (SDLC) of computer systems, ensuring validation is integrated at each stage
Create and execute test protocols for system verification, documenting and resolving any discrepancies or deviations
Oversee system changes through a controlled change management process, ensuring that modifications maintain compliance with validation and regulatory requirements
Ensure validation activities are thoroughly documented, including user requirements, functional specifications, test cases, results, and validation reports
Serve as a subject matter expert during regulatory audits and inspections, providing validation documentation and explaining strategies and processes to auditors
Provide training to team members and stakeholders on validation requirements and best practices, while staying updated on regulatory changes and emerging industry trends.
Requirements
Minimum of 3 years of experience as a Computer Systems Validation Specialist or similar role.
Demonstrable knowledge and skills in GxP and GxP FDA.
Proficiency in handling Computer Systems and System Validation.
Experience in Compliance Risk management related to IT systems.
Familiarity with FDA 21 CFR regulations and guidelines.
Expertise in Software Validation is a must.
Comprehensive understanding and application of Validation Models.
Proven experience in Validation Testing.
Excellent communication and problem-solving skills.
Bachelor's degree in Computer Science, Information Technology, or related field is desirable.
Technology Doesn't Change the World, People Do.
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
