Senior Specialist, CDS & SDMS, Delivery Lead

Job Description Senior Specialist- CDS & SDMS, Delivery Lead The Opportunity 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 organization 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 company’s 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 Technical Delivery Lead for the Empower CDS platform is responsible for planning, coordinating, and delivering system implementations, upgrades, and enhancements within regulated (GxP) environments. They oversee cross-functional teams, manage timelines, budgets, and risks, and ensure all activities meet validation and compliance requirements such as FDA 21 CFR Part 11. This role serves as the point of contact for the product owner, driving alignment between Business, IT, QA, and laboratory operations to ensure successful and compliant delivery outcomes. What Should you have : Primary: Waters Empower CDS and NuGenesis SDMS, Strong lab acumen in a QC Lab environment. GxP, FDA 21 CFR Part 11, Empower platform, risk management. Bachelor's degree or equivalent and a minimum of 1 years making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field. •Strong analytic, critical thinking and problem-solving skills •Experience in Waters Empower CDS and NuGenesis SDMS mandatory. •Strong lab acumen in a QC Lab environment. What you would do : •Lead end-to-end delivery for various projects on the Empower platform, including planning, resourcing, risk management, and on-time execution across upgrades, deployments, and enhancements. •Strong understanding of GxP, FDA 21 CFR Part 11, and data integrity requirements, ensuring all deliverables meet validation standards and are audit-ready. •Ability to align Business, IT, QA, and laboratory teams, manage vendor relationships, and communicate complex technical initiatives clearly to drive successful outcomes. • Good understanding of System Development Lifecycle (SDLC) activities and Computer System Assurance (CSA)• •Attention to detail. •Self-motivated •Experience in Pharma Industry with knowledge of cGMP and Laboratory processes. •Good Communication Skills including fluency in English Who we are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and everywhere else. For more than a century, we have been, 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 in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. #HYDIT20205 Required Skills: Animal Vaccination, Animal Vaccination, Cloud Computing, Configuration Management (CM), Critical Thinking, Customer-Focused, Data Integrity, Delivery Management, Demand Management, Detail-Oriented, DevOps, Digital Technology, Digital Transformation, Firewall Management, Information Technology Operations, ITIL Management, ITIL Service Delivery, IT Infrastructure Management, Meeting Facilitation, Network Security, NuGenesis SDMS, Project Delivery, Project Management, Service Delivery, Software Development {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/16/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R400599