Senior Validation Engineer, QRM

Cornerstone Research; United States; Remote; USD 146,000 - 235,000; Full time

Job summary

A leading company specializing in SaaS solutions for regulated industries is looking for a Senior Validation Engineer. This strategic role involves overseeing the IV&V lifecycle, managing software validation activities, and ensuring compliance in a dynamic environment. The successful candidate will join a culture that encourages curiosity and innovation, with a comprehensive compensation package in a remote setup.

Qualifications

• In-depth knowledge of regulatory frameworks such as GxP, GAMP 5.
• Minimum of 7 years’ experience leading validation projects.
• Hands-on experience validating regulated SaaS systems.

Responsibilities

• Oversee the IV&V lifecycle for validated SaaS Learning Management System.
• Collaborate with cross-functional teams to develop validation packages.
• Lead a team of validation engineers.

Skills

Leadership

Risk Management

Validation Methodologies

Analytical Skills

Excellent Communication

Education

Bachelor’s or Master’s degree in Information Systems, Computer Science, or related field

Job description

We're looking for a

Senior Validation Engineer, QRM

This role is Remote,United States

Cornerstone provides SaaS-based solutions tailored for customers in regulated industries such as Life Sciences, Banking, Manufacturing, Healthcare, and Government and ensures that our software systems meet both functional specifications and intended use for our regulated customers. The Senior Validation Engineer plays a vital role in this process through oversight of the Independent Verification and Validation (IV&V) efforts. The output is utilized and leveraged by regulated customers that purchase Cornerstone’s IV&V Maintenance Service. This position reports to the AVP, Quality and Risk Management (QRM) within the Cybersecurity Engineering & Assurance organization and is a strategic role within the company.

About the Quality and Risk Management (QRM) Team

The QRM team is responsible for establishing and maintaining the overarching Quality Management System (QMS) at Cornerstone. This system governs compliance across the company and provides regulatory expertise, operational support, and strategic consulting. Key areas of responsibility include:

• Regulatory expertise, consulting, and oversight to all functional areas within Cornerstone;
• Audit Management;
• Learning and Development Management;
• Document Management;
• Deviation Management;
• Quality Plan and CAPA Management;
• Independent Verification and Validation Management (regulated industry customers).

Role Responsibilities

As the Senior Validation Engineer, you will oversee the IV&V (Independent Verification & Validation) lifecycle for Cornerstone’s validated SaaS Learning Management System (LMS), which is deployed to customers in heavily regulated industries. You are a seasoned strategic leader and will ensure our software meets all validation requirements through structured methodologies, risk-based approaches, and regulatory best practices in a fast-paced environment.

In this role you will...

• Strategically manage validation activities for software releases and patches (three major Releases annually)
• Collaborate cross-functionally with Product, Engineering, and Software Quality Assurance teams to develop, support, and maintain a software validation package that demonstrates verification and validation activities for the Cornerstone Solution and is leveraged by customers in regulated industries
• Lead a team of validation engineers and drive timely customer-facing documentation and deliverables
• Develop and review essential validation deliverables such as Risk Assessments, Test Scripts, Functional Requirements and Traceability Matrices, and Summary Reports
• Apply risk-based validation techniques in accordance with GxP, GAMP 5, and global compliance frameworks
• Act as the point of contact for customer inquiries related to IV&V activities
• Monitor regulatory developments and integrate changes into internal procedures
• Work closely with the global Cybersecurity and Assurance Team to implement security standards across the organization
• Support audits, CAPA responses, and maintain documentation for the system lifecycle
• Represent Cornerstone in industry events, forums, and special interest groups to establish thought leadership and stay abreast of industry best practices
• Effectively communicate program status, risks, and outcomes to AVP, QRM.

You've got what it takes if you have...

• Bachelor’s or Master’s degree in Information Systems, Computer Science, or a related technical field (preferred)
• In-depth knowledge of regulatory frameworks such as GxPs (e.g., 21 CFR Part 11, 58, 210, 211, 820, EU Annex 11, etc.), GAMP 5, ALCOA++, ICH, GDPR, FedRAMP, HIPAA, PCI, ISO 9001/27001/27701, and NIST
• A minimum of 7 years’ experience leading validation projects in life sciences, healthcare, or financial services
• Hand-on experience validating (CSV) regulated SaaS systems, including Learning Management Systems or platforms used in the life sciences industry. The ideal candidate will have experience in a Technology company that supplies systems to customers who validate computer systems based on regulatory requirements and intended use
• Demonstrated ability to lead a team (at least two direct reports), effectively delegate, and maintain high standards under pressure
• A strong grasp of the SDLC, validation methods for SaaS environments, and risk management principles
• Excellent communication, presentation, organizational and documentation skills, with the ability to influence and collaborate with leadership and cross-functional teams.
• Excellent analytical, problem-solving, critical-thinking and decision-making abilities.
• Experience in utilizing AI in validation strategies is strongly preferred.
• Experience managing multiple concurrent projects and meeting demanding delivery timelines.
• Strong ability to follow through on all identified issues during the validation lifecycle (e.g., defects, and other issues associated with IV&V).
• Demonstrated commitment to valuing diversity and contributing to an inclusive working and learning environment
• Considerationfor privacy and security obligations

Key Competencies and Technical Capabilities

The Senior Validation Engineer must demonstrate strong leadership, technical expertise, and execution ability in managing a complex validation program. Core competencies include:

• Drive the full IV&V lifecycle including plan, execute, and report all releases and patches
• Lead and mentor a team of validation engineers, ensuring consistent delivery of high-quality work
• Elicit, from JIRA and other sources, Critical To Customer (CTC) requirements and document in detailed Software Requirements Specifications (SRSs)
• Produce and execute Software Test Scripts (STSs) to verify the CTC Requirements
• Produce professional-looking, customer-facing and audit-ready validation deliverables which follow the principles of Good Documentation Practice
• Conduct peer reviews and maintain internal knowledge-sharing articles to improve team efficiency
• Run daily stand-ups, tracking progress, addressing blockers, and delivering timely guidance
• Collaborate closely with Software Quality Assurance, Engineering and Product teams to resolve issues and align validation evidence with release objectives
• Willingness to work non-standard hours as needed to meet critical deadlines and release cycles

Our Culture:

Spark Greatness. Shatter Boundaries. Share Success. Are you ready? Because here, right now – is where the future of work is happening. Where curious disruptors and change innovators like you are helping communities and customers enable everyone – anywhere – to learn, grow and advance. To be better tomorrow than they are today.

Who We Are:

Cornerstone powers the potential of organizations and their people to thrive in a changing world. Cornerstone Galaxy, the complete AI-powered workforce agility platform, meets organizations where they are. With Galaxy, organizations can identify skills gaps and development opportunities, retain and engage top talent, and provide multimodal learning experiences to meet the diverse needs of the modern workforce. More than 7,000 organizations and 100 million+ users in 180+ countries and in nearly 50 languages use Cornerstone Galaxy to build high-performing, future-ready organizations and people today.

Total Rewards:

At Cornerstone, we are dedicated to inspiring excellence and pushing boundaries in everything we do. Our compensation strategy is based on three fundamental principles: equitable pay, market-driven research, and skill-based appraisals. As part of our mission to share success and empower individuals to thrive in an ever-changing world, the listed salary range is just one element of Cornerstone’s comprehensive compensation package. This compensation package may also include annual bonuses, short- and program-specific awards depending on the role, and a comprehensive benefit offering.The disclosed salary range reflects the geographic differential based on the location of the position if applicable. The starting salary for the successful applicant will depend on several job-related factors, including education, training, experience, certifications, location, business needs, and market demands. This range is based on a full-time position and may be adjusted in the future. Join us in shaping the future of work — tomorrow, together. Experience flexibility and empowerment in your career at Cornerstone. The BASE salary range for this position is: 146900 - 235000 USD.

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Equal Employment Opportunity has been, and will continue to be, a fundamental commitment at Cornerstone OnDemand. All qualified applicants are given consideration regardless of race, religion, color, gender, sex, age, sexual orientation, gender identity, national origin, marital status, citizenship status, disability, veteran status, or any other protected class as provided in applicable Federal, State, or Local fair employment laws. If you have a disability or special need that requires accommodation, please contact us at [e-mail] or [phone].

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