Sr Validation Engineer

Role Description:

This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements.

The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated.

Roles & Responsibilities:

• Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the 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 withGxP, 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 and Experience:

• Masters degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR

• Bachelors 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 21 CFR Part 11.

• Expertisein 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, Veeva Vault Management etc.

Good-to-Have Skills:

• Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management)

• Experience of DevOps, Continuous Integration and Continuous Delivery methodology

• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• 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

Shift Information:

• This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.