Validation Specialist II

The Validation Specialist II will perform business analysis, validation, and testing processes required to support the software development and implementation process in the regulated clinical research field.  The Validation Specialist II also directs the validation testing of ensuring final outcomes meet specified requirements.  Lastly, this position ensures and facilitates corporate compliance with applicable regulations as they affect software development, implementation and maintenance in a regulated environment including participation in audits as they pertain to software projects and systems.

Responsibilities

• Work closely with business primes to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process
• Identify and schedule project deliverables, milestones, and tasks required to validate software releases
• Research, develop, and write content for the validation of software products and services
• Prepare and maintain documentation and publications relating to users, systems, programming, operations, products, services, testing and validation
• Create graphical images, flow charts, and diagrams for inclusion in documentation
• Lead and/or participate in developing SOPs (Standard Operating Procedures) that are followed to ensure regulatory compliance in developing or implementing software
• Ensure adherence to SOPs, regulatory validation, and quality assurance plans by software developers and their customers
• Act as an independent quality reviewer for peer software validations as well as openly accept critical quality reviews of one’s own work with the goal of producing high quality documentation to support audits
• Ensure that developed application documents meet all project and SOP requirements
• Ensure compliance with testing environment requirements for validation testers
• Create and/or execute acceptance tests for software under development and/or commercial off the shelf software products
• Coordinate the recruitment, training, and testing of qualified testers to perform acceptance testing for new software releases

Requirements

• Bachelor's degree or international equivalent required with a minimum of 3 - 5 years of professional work experience is required within the clinical research industry; or an equivalent combination of relevant and preferred education and/or work experience
• Validation experience in GxP environment is required
• Demonstrates strong proficiency in validation methodologies, risk‑based validation, and regulatory expectations with minimal supervision
• Working knowledge of 21 CFR Part 11 regulations and a project management background is helpful
• Microsoft Word, Microsoft Visio, Microsoft PowerPoint, Microsoft Project, Microsoft SharePoint, Microsoft Excel, Adobe Acrobat
• Must have the ability to work as part of a cross-disciplinary team and to communicate and relate to a diverse number of co-workers
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s. Fluency in both English and local languages.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

Please submit your CV / resume in English