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Position: Computer Systems Validation (CSV) Lead 

Reports to: Chief Product and Compliance Officer (CPO)  

Location: Remote (Headquarters in Boston and San Francisco) 

At GxSpeed, our mission is to bring innovative solutions and life-saving therapies to people faster. By blending strategic execution, technological innovation and operational excellence, we optimize our clients’ operations to drive down unit economics and accelerate growth.  As a forward-thinking company, we are committed to driving change and making a significant impact on the life sciences ecosystem. 

As we continue to expand, we’re looking for passionate and driven professionals to join our team. This is an exciting opportunity to work in a fast-paced, entrepreneurial environment and directly contribute to the growth and success of the firm. 

Position Overview:  

We are seeking a highly motivated and experienced Computer Systems Validation (CSV) Lead to join our team. The CSV Lead will be responsible for leading and executing validation activities for computerized systems, including AI-based systems, used in our FDA-regulated environment (e.g., pharmaceutical, biotechnology, medical device). This role requires a strong understanding of GAMP 5, 21 CFR Part 11, and other relevant regulatory guidelines, with a focus on emerging technologies and Computer Systems Assurance (CSA) principles. The ideal candidate will have a proven track record of successfully managing complex validation projects and possess excellent communication and leadership skills. 

Key Responsibilities: 

• Lead and manage the full lifecycle of computer system validation activities, including planning, execution, and reporting, in accordance with applicable regulations (21 CFR Part 11, EU Annex 11, GAMP 5, etc.). 
• Develop and review validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS), Test Protocols (IQ, OQ, PQ), Traceability Matrices, Validation Summary Reports, and other relevant documentation.    
• Collaborate with cross-functional teams (e.g., IT, Quality, Engineering, Manufacturing) to ensure validation requirements are met. 
• Provide guidance and training to project teams on CSV principles, including CSA and AI validation considerations. 
• Perform risk assessments, including those specific to AI/ML systems, to determine the appropriate level of validation effort. 
• Oversee the execution of validation testing and ensure adherence to approved protocols. 
• Investigate and resolve deviations and discrepancies identified during validation activities. 
• Maintain validation documentation and ensure its accuracy and completeness. 
• Stay up-to-date on current regulatory requirements and industry best practices related to CSV, including emerging guidance on AI/ML validation. 
• Contribute to the development and improvement of CSV procedures and processes, incorporating CSA principles. 
• Manage and mentor junior validation staff, as applicable. 
• Participate in audits and inspections by regulatory agencies. 
• Manage vendor validation activities as needed. 
• Ensure data integrity principles are followed throughout the validation lifecycle. 
• Apply Computer Systems Assurance (CSA) principles to streamline validation activities and focus on critical aspects of system functionality. 
• Develop and execute validation strategies for AI/ML-based systems, addressing specific challenges such as model training, data bias, and explainability. 

Qualifications & Skills: 

• Bachelor's degree in a scientific, engineering, or related field. 
• Minimum of 7 years of experience in Computer System Validation within a regulated industry (e.g., pharmaceutical, biotechnology, medical device). 
• Thorough understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and other relevant regulatory guidelines. 
• Experience with various types of computerized systems, including but not limited to:  
• Laboratory Information Management Systems (LIMS) 
• Enterprise Resource Planning (ERP) systems 
• Manufacturing Execution Systems (MES) 
• Quality Management Systems (QMS) 
• Chromatography Data Systems (CDS) 
• Strong knowledge of validation methodologies (e.g., Waterfall, Agile). 
• Excellent written and verbal communication skills. 
• Strong problem-solving and analytical skills. 
• Ability to work independently and as part of a team.    
• Experience with audit and inspection management. 

Preferred Qualifications: 

• Relevant certifications (e.g., CSQE, CISA). 
• Experience with automated testing tools. 
• Experience in a GMP environment. 
• Experience with validating AI/ML-based systems. 
• Knowledge of Computer Systems Assurance (CSA) principles and their application in validation. 

What We Offer: 

• An innovative and quickly-growing company with significant opportunities for professional growth. 
• Access to cutting-edge tools, technologies, and resources to support your professional development. 
• The opportunity to work on impactful products and services that improve healthcare outcomes and accelerate Life Sciences innovations. 
• Competitive salary based on experience, with performance-based incentives and the opportunity to transition into a permanent, full-time role after the contract period. 
• Enjoy the benefits of a flexible work environment, with remote work options and the ability to manage your work schedule. 

At GxSpeed, you will have the opportunity to work with a diverse and talented team of professionals on cutting-edge projects in the Life Sciences space. You will be part of a company that values innovation, continuous learning, and growth. We offer a dynamic and supportive environment where your contributions will have a direct impact on our success and the success of our clients.  

If you’re a strategic, results-driven CSV Lead who thrives in a collaborative, fast-paced environment, we’d love to hear from you! 

Email your resume to kelly.protasewich@gxspeed.com if you are a good fit for this role.

GxSpeed is an equal opportunity employer and is committed to creating a diverse environment. We encourage individuals of all backgrounds to apply.