**Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity!** CTG's premier client has a contract assignment for a Software Validation Engineer. **Type:** Contract **Job Title:** Software Validation Engineer (Manufacturing) **Location:** Remote position, must be willing to work EST schedule **Pay Rate:** $55.00-$60.00/hr **Work Hours:** M-F 8am-5pm **Education:** Bachelor's degree in a relevant field required **Description** This position uses industry best practices and quality engineering principles to create and enforce a rigorous software validation program as part of the overall product quality architecture. The role supports evolving customer and business needs across all stages of product innovation, design/development controls, and business/manufacturing/quality software system implementation. The Software Engineer II will work closely with various functional teams, including Manufacturing, R&D, Quality, Engineering, Procurement, and Business Operations, to develop and implement a standardized, lean, and compliant approach to software verification and validation. **Responsibilities:** • Standardize and streamline validation processes to ensure compliant software delivery • Coordinate with functional groups to understand, document, and validate software requirements • Lead and support continuous improvement initiatives within the organization • Serve as a Quality representative on projects of varying scale and complexity • Act as SME, Trainer, and Coach for software IQ/OQ/PQ validation systems • Apply best quality engineering practices to support project teams in software validation • Conduct internal audits to ensure compliance with quality systems • Develop and maintain technical documentation aligned with industry standards and regulations (ISO, FDA, EU, etc.) **Requirements:** • 5+ years of experience in pharmaceutical, medical device, or biotechnology industry software quality engineering and assurance • Background in 21 CFR Part 11-compliant software validations, including inspection systems, vision systems, MES, and material handling systems • Knowledge of industry regulations and standards (GAMP, GMPs, ISO 9001, ISO 13485, 21 CFR Part 820) • Experience with software used for data collection, storage, analysis, project management, and operational management systems • Proficiency in Microsoft Office applications • Strong communication skills and ability to work across all organizational levels • Ability to work independently, manage multiple tasks, and drive initiatives • Strong decision-making and problem-solving abilities • Experience in software validation within integrated systems • Knowledge of manufacturing processes and relevant software quality assurance practices **A** **dditional Information:** • No third-party resumes will be accepted • Drug testing and/or other employment-related inquiries may be conducted • CTG will consider employment-qualified applicants with criminal histories in compliance with local, state, and federal laws • All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third-party vendors) • CTG is an Equal Employment Opportunity employer • CTG is an E-Verify Company To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary expectations to **Jamie.Robinson** **@ctg.com** **.** The expected base salary for this position is $60.00/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, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. For more information, visit www.ctg.com . Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations. 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.