Senior Validation Consultant

Position Overview:

We are seeking a skilled Validation Specialist to join our team.

This role will be responsible for collaborating with cross-functional teams to ensure the validation of systems and processes meets regulatory requirements.

The ideal candidate will have experience in defining and implementing validation strategies, creating and driving validation protocols, and ensuring compliance with GxP regulations.

• Key Responsibilities:
• Develop and manage test cases, protocols, and validation documentations within the Veeva Validation Manager Vault.
• Provide technical support in validation to meet objectives of quality, output, and cost in developing, troubleshooting, standardizing, and improving new and existing validation methods/procedures.
• Prepare, implement, document, and report validation protocols in line with GxP and other regulatory requirements and standards.
• Ensure that all validation test procedures are in line with current technology, corporate, and governmental regulations.
• Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate.
• Implement test scripts to ensure system compliance with regulatory requirements and organizational standards.
• Identify, document, and track defects during the testing process.
• Collaborate with development teams to resolve defects and validate fixes.
• Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards.
• Maintain comprehensive audit trails and validation documentations to support regulatory inspections.
• Configure and optimize workflows within the Validation Manager Testing Vault to streamline test management and approval processes.
• Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements.
• Act as a liaison between technical teams and customers to ensure system requirements are met.
• Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes.
• Offer ongoing support to ensure effective use of the platform.
• Generate reports and dashboards to monitor testing progress, defect trends, and validation status.

• A Master's degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT, or a related field OR
• A Bachelor's degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT, or a related field OR
• Diploma with years of experience in Computer Science, Business, Engineering, IT, or a related field.
• Solid understanding of the Veeva Clinical Platform and business processes.
• 6-8 years of Global Pharmaceutical industry experience.
• Solid understanding of pharmaceutical clinical operation and data management business processes.
• Experienced in pharmaceutical regulations and specifications.
• Solid understanding of GxP regulations, specifically 21 CFR Part 11.
• Expertise in defining and implementing validation strategies aligned with regulatory requirements.
• Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)).
• Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity.
• Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager, Vault, etc.

• Proficiency in automation tools and validation software.
• Experience with DevOps, Continuous Integration, and Continuous Delivery methodologies.
• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile, etc.).

This is an exciting opportunity to work with a dynamic team and contribute to the success of our organization. We offer a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

As a Validation Specialist, you will have the opportunity to develop your skills and expertise in validation and gain valuable experience in the pharmaceutical industry.

We are committed to providing a safe and inclusive work environment for all employees. We encourage diversity and inclusion in the workplace and provide opportunities for professional growth and development.