At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Software Validation Lead provides technical leadership and strategic oversight for the validation lifecycle of regulated computerized systems supporting business operations within a Medical Device environment. The role is responsible for ensuring computerized systems are developed, implemented, enhanced, and maintained in a validated state through the application of risk-based validation methodologies, regulatory compliance, and industry best practices. This position partners with cross-functional teams to develop validation strategies, guide testing and data migration/transformation activities, support system lifecycle changes, drive process improvements, support supplier/3rd Party vendors oversight validation activities, and ensure solutions meet business, quality, cybersecurity, and GxP requirements and keep the system audit-ready.

Work Location: Bangalore

Work Mode: Hybrid (3 Days in office)

Shift Timing - 3:00 PM - 12:00 AM

How You'll Create Impact

- Leads multiple concurrent high-complexity software validation projects, enhancements, and changes which align to defined procedures
- Leads gap and risk analysis of IT system changes to ensure appropriate testing levels/strategies are identified as per CSV/CSA principles across projects and platforms.
- Works with project teams to develop, review, and approve comprehensive risk-based validation lifecycle documentation, including Validation Plans, Risk Assessments, Requirements, Traceability Matrices, IQ/OQ/UAT Test cases, Validation Summary Reports, and Change Control documentation aligned with CSV, CSA, GAMP 5, and regulatory expectations




- Guides testing to ensure the quality of software meets the approved intended use prior to production release
- Define risk-based verification strategies, advising project teams on functional, integration, regression, user acceptance, infrastructure, and automated testing approaches based on system complexity, intended use, and regulatory risk.
- Develop validation strategy for data migration/transformation activities by defining migration verification methodologies, reconciliation processes, sampling strategies, traceability requirements, data integrity controls, and acceptance criteria to ensure complete and accurate migration of regulated data
- Provides change management support for regulated applications by performing change impact assessments, reviewing change requests, defining regression testing requirements, and evaluating implementation risks
- Develop and deliver structured training and mentoring programs on Computer Software Assurance (CSA), Computer System Validation (CSV), validation lifecycle processes, ALM, and risk-based testing methodologies to improve process consistency
- Drive continuous improvement initiatives by evaluating existing validation processes, identifying operational inefficiencies, recommending standardized methodologies, and implementing best practices that improve compliance, consistency, quality, and delivery efficiency
- Acts as a cross-functional resource by partnering with Business, Quality, and Technical teams and ensures compliance with regulatory and corporate policies and standards.
- Provide validation guidance for cloud-based, SaaS, and hybrid-hosted applications.
- Meet defined deadlines for assigned tasks and scheduled deliverables
- Support internal, customer, supplier, and regulatory audits by providing Computer System Validation expertise and required validation evidence, and inspection-ready documentation.
- Provides mentoring and coaching to junior team members
- Apply concepts of appropriate standard methodologies and best practices
- Leads the adoption of validation practices for AI-enabled systems by developing risk-based validation approaches





Preferred Validation Experience

- Partner with Information Security and Infrastructure teams to assess cybersecurity-related system changes and determine validation impact, testing requirements, and compliance considerations.
- Provide validation guidance for assessment of supplier controls, infrastructure qualification reliance, and shared responsibility considerations

What Makes You Stand Out
- Experience with Medical Device or Pharmaceutical industries desired.
- Advanced knowledge of applicable global regulations and industry guidance, including 21 CFR Part 11, 21 CFR Part 820, GAMP 5 (2nd Edition), Computer Software Assurance (CSA), Data Integrity (ALCOA+), and risk-based validation methodologies.
- Demonstrated ability to interpret regulatory expectations and translate them into practical validation strategies for enterprise software implementations and system changes.
- Solid understanding of enterprise application architecture, system integrations, APIs, interfaces, data flows, middleware, cloud technologies, authentication mechanisms, and database concepts sufficient to assess validation impact and testing.
- Working knowledge of Agile, V-model, Waterfall, Hybrid SDLC methodologies.
- Highly motivated self-starter with strong attention to detail and proven ability to prioritize and scope work.
- Excellent verbal and written communication skills.
- Flexibility to handle demands of a rapidly growing and changing workplace.
- General wide breadth of knowledge of the different Microsoft Office applications.
- Advanced experience with test management tools (ALM)
- Working knowledge of validation considerations for AI-enabled software solutions.
- Ability to assess validation implications of emerging technologies while ensuring continued compliance with regulatory expectations.

Your Background
- Bachelor’s degree in information technology, Engineering, Science, or related field.
- A minimum of 10plus years in an FDA/ISO regulated industry working on Computerized System Validation (CSV) activities.
- Demonstrated experience supporting GxP regulated computerized systems.
- Strong understanding of Software Development Lifecycle (SDLC) and Computer Software Assurance (CSA).
- Experience leading validation activities for enterprise software implementations, upgrades, migrations, and integrations.

Travel Expectations

Up to 15%

EOE/M/F/Vet/Disability

📌 Software Validation Lead (Bengaluru)
🏢 Zimmer Biomet
📍 Bengaluru