Job Title: Sr. Validation Engineer
Location: India - Hyderabad (On Site)
Date Posted: Feb. 04, 2025
Category: Quality
Shift Information: Second Shift (2:00 PM to 10:00 PM IST)
Role Description:
The Sr. Validation Engineer will collaborate with Business Analysts, Data Architects, Data Engineers, AI/ML Engineers, and Product Managers to create and implement validation strategies and deliverables for IT systems. This role is pivotal in ensuring compliance, efficiency, and innovation in managing data validation processes. The successful candidate will contribute to continuous improvements and automation within the validation program while maintaining adherence to regulatory and validation procedures.
Key Responsibilities:
Collaborate with System Architects and Product Owners to manage validation strategy and deliverables for GxP applications.
Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault.
Execute 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 comply with GxP, FDA 21 CFR Part 11, and other regulatory standards.
Maintain comprehensive audit trails and validation documentation to support regulatory inspections.
Configure and optimize workflows within the VM 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 stakeholders to ensure system requirements are met.
Provide training to end-users on Veeva VM Testing Vault functionalities and best practices.
Offer ongoing support to ensure effective use of the platform.
Generate reports and dashboards to monitor testing progress, defect trends, and validation status.
Basic Qualifications:
Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Functional Skills:
Must-Have Skills:
Solid understanding of GxP regulations, specifically FDA 21 CFR Part 11.
Expertise in defining and executing validation strategies aligned with regulatory requirements.
Experience in creating and executing 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 and Veeva Vault Management.
Good-to-Have Skills:
Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management).
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.
Professional Certifications:
SAFe for Teams certification (Preferred)
Veeva VM certification (Preferred)
Soft Skills:
Able to work under minimal supervision.
Skilled in providing oversight and mentoring team members.
Demonstrated ability in effectively delegating work.
Excellent analytical and gap/fit assessment skills.
Strong verbal and written communication skills.
Ability to work effectively with global, virtual teams.
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Team-oriented, with a focus on achieving team goals.
Strong presentation and public speaking skills.
Why Join Us:
Be part of a cutting-edge biotech company that is committed to innovation and quality.
Work with cross-functional global teams, driving impactful validation strategies.
Opportunities for continuous learning, career advancement, and skill enhancement.
Competitive salary and comprehensive benefits package aligned with local industry standards.
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