Validation Specialist II/III
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Validation Specialist ensuring compliance in regulated clinical research software development processes. Leading validation testing, documentation, and adherence to regulatory standards.
Responsibilities:
- Perform business analysis, validation, and testing processes to support software development in regulated clinical research
- Direct validation testing to ensure final outcomes meet specified requirements
- Ensure and facilitate corporate compliance with applicable regulations concerning software development and maintenance
- Work closely with business primes to document requirements and business processes
- Identify and schedule project deliverables, milestones, and tasks for software validation
- Research, develop, and write validation content for software products and services
- Prepare and maintain documentation relating to users, systems, programming, and validation
- Create graphical images, flow charts, and diagrams for documentation
- Develop and/or participate in SOPs to ensure regulatory compliance
- Ensure adherence to SOPs, regulatory validation, and quality assurance plans
- Act as an independent quality reviewer for peer software validations
- Ensure developed application documents meet project and SOP requirements
- Ensure compliance with testing environment requirements for validation testers
- Create and/or execute acceptance tests for software under development or commercial products
- Coordinate recruitment, training, and testing of qualified testers for acceptance testing
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.
Similar Jobs
Project Scheduler – Industrial Construction
Project Scheduler for industrial construction managing complex projects across the United States. Seeking experienced professional with strong Primavera P6 expertise for remote/travel-based work.
Project Scheduler – Industrial Construction
Project Scheduler supporting industrial construction projects throughout the U.S. Collaborating with project leadership to develop, maintain, and analyze project schedules.
Project Scheduler – Industrial Construction
Project Scheduler for large-scale industrial and mission critical construction projects. Working remotely and traveling to active job sites across the United States.
Project Scheduler – Industrial Construction
Project Scheduler supporting large-scale industrial and mission critical construction projects. Requires Primavera P6 expertise and travel to job sites across the U.S.
Intake Specialist
Intake Specialist managing inbound client inquiries for HireHawk. Conducting intake interviews and ensuring professional client interactions in a remote setting.
Instructor – Clinical Chemistry
Remote instructor for Clinical Chemistry course at established educational provider. Responsibilities include planning and conducting online classes and coordinating with course management.
Campaign and Organizing Associate
Battlegrounds Campaign and Organizing Associate supporting local Indivisible groups in Iowa. Training and coaching group leaders for effective grassroots organizing and electoral victories.
Campaign and Organizing Associate
Campaign and Organizing Associate for Battlegrounds, partnering with local Indivisible groups in Alaska. Focused on training and building effective teams to strengthen grassroots power.
Production Clerk
Production Clerk ensuring accurate customer data entry and fulfillment of customer requests in Virginia. Engaging with customers and maintaining compliance in data management.
ESL Teacher, Part-Time – Adult Learners
ESL Teacher role focused on teaching English to adult professionals in small group sessions. Utilizing immersive technology to enhance learning experiences for real-world fluency.
Licensed Clinical Social Worker
Counselor leading dynamic group therapy sessions in a mission-driven recovery community. Collaborating with clinical teams and contributing to member-centered care for addiction healthcare.
Senior Leadership Coach
Senior Leadership Coach promoting personal development and help transforming lives in the leadership industry. Offering flexible remote work opportunities for impactful growth.
Distributor
Independent Distributor promoting personal development products with flexible work from anywhere. Join GearUp2Success and earn income while integrating with your current commitments.
Member Intake Specialist
Member Access Specialist at Eleanor Health connecting individuals to addiction and mental health care services through a consultative approach. Engaging with prospective members and advocating for whole-person care.
Psychiatric Nurse Practitioner, Part-Time
Part-Time Psychiatric Nurse Practitioner providing telemedicine care for addiction and psychiatric disorders at Eleanor Health. Involves collaboration with medical staff and continuous quality improvement initiatives.
Loss Control Representative – Western WI
Loss Control Representative responsible for conducting risk assessments and servicing accounts in Western Wisconsin. Field-based position covering Madison to La Crosse from a home office.
Loss Control Representative
Loss Control Representative at West Bend conducting onsite risk assessments and consulting with underwriting partners. Fostering relationships with agents and ensuring safety planning for clients in Virginia.
Vibe Coding Course Instructor
Instructor developing a 4-week Vibe Coding course for DavidsonX to teach AI-driven no code app development. Working with a team, leveraging digital education for global reach.
Reservations Revenue Specialist
Reservations Revenue Specialist responsible for financial accuracy in luxury travel bookings. Collaborating with partners and conducting audits to maintain margin integrity and operational efficiency.
Travel Coordinator
Travel Coordinator responsible for bringing luxury travel itineraries to life for UJV's clients. Collaborating with in-country teams to ensure seamless travel experiences focusing on accuracy and client preparation.