Senior Specialist, CDS & SDMS, Validation

About the role

Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our companys' IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role overview: The Senior Technical Writer & Validation specialist for the Empower , CDS platform is responsible for authoring and maintaining high-quality controlled documentation, including SOPs, Job aids, and lifecycle deliverables (IQ/OQ/PQ) in regulated (GxP) environments. They lead validation efforts, ensure compliance with FDA 21 CFR Part 11 and data integrity standards, and collaborate with QA, IT, Business, and laboratory teams to support system changes and updates. This role also reviews and mentors contributors, drives documentation standards, and ensures consistency and accuracy across all Empower-related materials. What Should you have : Primary skill - SOP, IQ/ OQ/ PQ, GxP, computer system Validation(CSV),Waters Empower CDS and NuGenesis SDMS, FDA 21 7+ years in Software Experience. Bachelor's degree or equivalent and a minimum of 7 years making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field. -Regulatory & Validation Expertise: Deep knowledge of GxP, FDA 21 CFR Part 11, and computer system validation (CSV), with hands-on experience authoring and executing I IQ/OQ/PQ test scripts in the digital platform. What will you do in this role: -You will produce, review, and manage high-quality SOPs, validation protocols/reports, and lifecycle documentation with strong adherence to document control standards, traceability, and audit readiness. -Cross-Functional Leadership & Communication: Proven ability to collaborate with QA, IT, Business, and laboratory stakeholders, translate complex technical concepts into clear documentation, and mentor junior writers while driving consistency and best practices. - You will lead validation efforts, ensure compliance with FDA 21 CFR Part 11 and data integrity standards, and collaborate with QA, IT, Business, and laboratory teams to support system changes and updates - Experience in Waters Empower CDS and NuGenesis SDMS mandatory. - Good understanding of System Development Lifecycle (SDLC) activities and Computer System Assurance (CSA) -Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc. -Strong analytic, critical thinking and problem-solving skills -Attention to detail- to mentor Juniors. -Self-motivated -Experience in Pharma Industry with knowledge of cGMP and Laboratory processes. -Good Communication Skills including fluency in English Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing , bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work

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Job Description Senior Specialist CDS &SDMS Validation

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