Role Overview :

As a Quality Validation Engineer, you will serve as a critical bridge between technical system integrity and regulatory compliance. You will be responsible for overseeing the end-to-end validation lifecycle of complex enterprise systems, ensuring that our digital infrastructure meets stringent industry standards. You will collaborate closely with cross-functional teams, including IT architects, product owners, and regulatory affairs specialists, to ensure that system deployments are not only functional but also audit-ready.

By maintaining rigorous oversight of our Quality Management Systems and validation protocols, you directly influence the reliability of our business processes, ensuring seamless operations for our global stakeholders and mitigating risks associated with system performance and data integrity.

Key Responsibilities :

- Execute comprehensive Computer System Validation (CSV) strategies to ensure all software deployments align with GMP requirements and internal quality standards.

- Manage the full lifecycle of CAPA and Root Cause Analysis (RCA) processes to resolve system deviations and prevent recurrence, thereby maintaining high operational stability.

- Oversee Capacity and Availability Management to ensure that enterprise systems perform optimally under varying loads, supporting uninterrupted business continuity.

- Configure and validate CPQ workflows to ensure accurate pricing and quoting logic, minimizing downstream errors in the sales and fulfillment cycle.

- Perform complex data queries using SOQL and SOSL to extract, analyze, and validate data integrity within SAP IQ and related database environments.

- Implement Statistical Process Control (SPC) methodologies to monitor system performance trends, allowing for proactive adjustments before quality thresholds are compromised.

- Maintain and update the Quality Management System (QMS) documentation to ensure full compliance with evolving regulatory landscapes and internal audit requirements.

Required Skillset :

- Demonstrated expertise in managing Computer System Validation (CSV) and process validation within highly regulated environments, ensuring all systems meet GMP and industry-specific compliance benchmarks.

- Proficient in leveraging SAP IQ and advanced query languages like SOQL/SOSL to perform deep-dive data analysis and system health checks.

- Proven ability to lead Root Cause Analysis (RCA) and CAPA initiatives, translating technical findings into actionable quality improvements for senior stakeholders.

- Strong understanding of CPQ architecture and the ability to validate complex business logic to ensure seamless integration across the sales ecosystem.

- Exceptional analytical skills with a focus on Statistical Process Control (SPC) to drive data-backed decision-making and process optimization.

- Excellent communication skills with the ability to articulate complex technical validation requirements to non-technical stakeholders and regulatory auditors.

- A Bachelor's or Master's degree in Engineering, Information Technology, or a related field, with 4 to 9 years of professional experience in quality assurance or validation roles.

- Highly adaptable to a hybrid work environment, demonstrating the ability to coordinate effectively with distributed teams across metro locations.