Solution Architect, Validation & Testing

Job Summary

In this role, you will be responsible for handling various computer system validation activities for different cross functional programs across West Pharma.

Essential Duties and Responsibilities

• Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
• Perform system impact assessments and risk assessments to define appropriate validation scope and strategy.
• Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
• Demonstrate strong understanding of computerized systems, their intended use, data flows, and system lifecycle to ensure appropriate validation controls are established.
• Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
• Ensure compliance with Data Integrity (ALCOA+) principles, including audit trails, access management, and electronic records controls.
• Support deviation management, change control assessments, and periodic review activities for validated systems.
• Participate in internal audits and regulatory inspections, providing validation rationale and documentation support.
• Promote risk-based and CSA-aligned validation practices within project teams.
• Provide mentorship and functional guidance to junior validation team members.

Education

• Bachelor s degree in computer science, or Information Technology

Work Experience

• Must have 3 years of relevant experience preferably in Medical Device or Pharma validation of Software

Preferred Knowledge, Skills and Abilities

• Must understand tools like SAP, QMS, LIMS, validation or testing tools.
• Strong understanding of GxP computerized system lifecycle principles (GAMP 5, risk-based validation, CSA approach).
• Working knowledge of global regulatory requirements including 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), and applicable GMP regulations.
• Ability to interpret system functionality, data flows, and intended use to determine appropriate validation controls.
• Sound knowledge of risk assessment methodologies and their application in validation strategy development.
• Ability to guide cross-functional teams in integrating validation requirements during system implementation and changes.
• Strong documentation review skills with attention to compliance, traceability, and audit readiness.
• Effective communication skills to translate regulatory expectations into practical project requirements.
• Ability to identify compliance gaps and recommend risk-based remediation strategies.
• Capability to manage multiple validation activities in a structured and organized manner.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Shift

• Occasional on-call work required.
• Prefer 12pm - 9pm India time. Willingness to work outside of these hours as needed.
• Ability to work in a global and virtual environment and to effectively prioritize and execute tasks in a high-pressure environment.

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