Senior Validation Specialist

We are looking for an experienced Validation reviewer to join our Client's team in Costa Rica. This role supports the project team in developing and implementing a software validation strategy for the Implementation project, ensuring compliance with applicable external regulatory requirements.Provides expertise on software validation requirements to Scrum teams responsible for validating SAP and interfaced applications. Conducts independent reviews and approves validation deliverables in accordance with applicable procedures and the Implementation Project Validation Plan.
The role will primarily focus on the Implementation project, its associated applications and interfaces with other systems. The position requires expertise in software validation within an Agile environment.
Overview of the role:Act as an independent validation reviewer for an ERP Implementation project providing validation direction and guidance to product teams.As an independent validation reviewer, communicate with the team and gain alignment on overall validation approachWorks with Validation Manager, Product Owners and Leads to understand priorities and plans to provide input to resource and time allocation accordingly.Review and approve validation deliverables per applicable procedures and Master Validation Plan.Responsible for judging procedural compliance to confirm that the work was completed according to the procedures and processes.Develop and maintain planning deliverables such as validation plan, test plan, configuration plan, reports etc.Ensures a risk-based validation strategy is implemented. Key contributor to the team developing and maintain the risk analysis deliverables.Analyze test strategies, develop test plans, and review test deliverables including traceability matrix.Review changes, analyze impacts and guide product teams on change control process.Work with the team to ensure tools are validated.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.Possess a fundamental understanding of quality philosophies, principles, methods, tools, standards and regulatory requirements.Understand systems architecture and be able to implement software development and maintenance processes, quantify the fundamental problems and risks associated with various software development methodologies.Able to apply project management principles and techniques as they relate to software project planning, implementation and tracking. Must be able to evaluate and manage risk.Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the company Quality Policy.Establishes and promotes a work environment that supports the Quality Policy and Quality System.Minimum 3 years of experience in software system validation or equivalent within a GXP environment especially with enterprise level application.Prior experience with SAP validation is preferred.Experience with Agile software development methodologies preferred.Strong decision-making abilities under pressure.Good familiarity with the FDA, ISO and/or quality requirements associated with developing and validating products in a regulated industry.Excellent communication skills (English & Spanish) (written and oral).