Computer Software Assurance (CSA) Consultant

CTG is seeking an experienced Computer Software Assurance (CSA) Consultant to support validation and compliance initiatives for GxP-regulated IT systems within a pharmaceutical/life sciences environment. The ideal candidate will possess extensive experience with Computer Software Assurance (CSA), Computer System Validation (CSV), risk-based validation methodologies, and regulatory compliance. This role partners closely with business and implementation teams to ensure compliant system implementations, validation documentation, and successful project delivery. Location: Remote Duration: 6 Months

Key Responsibilities

Lead CSA and CSV activities for GxP-regulated systems throughout the system lifecycle. Develop and execute risk-based validation strategies and testing approaches. Author and review validation deliverables, including Validation Plans, Test Strategies, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports. Facilitate solution design sessions with implementation teams and business stakeholders. Ensure compliance with 21 CFR Part 11, EU Annex 11, ALCOA+, ISPE CSA guidance, and internal quality standards. Support Quality Management System (QMS) processes, including deviation management, CAPA, and change control. Validate data migration activities and establish migration rules for system implementations. Provide validation support for Veeva and ServiceNow applications. Collaborate with cross-functional teams to deliver compliant, high-quality technology solutions.

Required Qualifications

Deep expertise validating GxP-regulated IT systems within the pharmaceutical or life sciences industry. Strong knowledge of Computer Software Assurance (CSA) and Computer System Validation (CSV) methodologies. Experience with end-to-end IT validation and risk-based testing. Comprehensive understanding of 21 CFR Part 11, Annex 11, ALCOA+, and GxP compliance requirements. Hands-on experience with change control, CAPA, deviation management, and validation documentation. Working knowledge of Veeva and ServiceNow platforms. Excellent communication, documentation, analytical, and collaboration skills. Preferred Experience 5+ years of CSA, CSV, or IT Quality experience in regulated environments. Experience supporting enterprise software implementations and upgrades. Ability to lead validation efforts while partnering effectively with business and technical teams. Education Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline preferred. Equivalent professional experience will be considered. Excellent verbal and written English communication skills and the ability to interact professionally with a diverse group are required. CTG does not accept unsolicited resumes from headhunters, recruitment agencies, or fee based recruitment services for this role. To Apply: To be considered, please apply directly to this requisition using the link provided. Kindly forward this to any other interested parties. Thank you! The expected base salary for this position ranges from $50.00 to $55.00/hour. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, market factors, and where applicable, licensure or certifications obtained. In addition to salary, a competitive benefit package is also offered. About CTG CTG, a Cegeka company, delivers IT and business solutions that enhance clients’ digital agility, empowering them to seize new opportunities and overcome any challenge. Backed by more than 60 years’ experience and a commitment to being a reliable, results-driven partner, we work shoulder to shoulder with clients to shape digital together. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. With more than 9,000 team members in over 15 countries, we combine global expertise with local insight to deliver innovative solutions. We operate across the Americas, Europe, and India, working with over 3,000 clients in many of today's highest-growth industries. Together, we shape what’s next—working shoulder to shoulder to deliver impactful solutions for our clients and society. Our culture is built by the people who work at CTG, the values we hold, and the actions we take. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. At CTG, you’ll find a workplace where you are encouraged to grow, supported in your ambitions, and empowered to shape your own career journey. For more information, visit www.ctg.com. CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. CTG is an Equal Opportunity Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. CTG is fully committed to promoting employment opportunities for members of protected classes.