Senior Specialist, CDS & SDMS, Validation at Merck Sharp & Dohme Corp. /Netherlands

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

08 Sep, 26

Salary

0.0

Posted On

10 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SOP, IQ/OQ/PQ, GxP, Computer System Validation, Waters Empower CDS, NuGenesis SDMS, FDA 21 CFR Part 11, SDLC, Computer System Assurance, JIRA, Microsoft Teams, cGMP, Technical Writing, Data Integrity, Stakeholder Management, Critical Thinking

Industry

Pharmaceutical Manufacturing

Description

Job Description Senior Specialist CDS &SDMS Validation 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 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. Who we are 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 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. #HYDIT2025 Required Skills: Animal Vaccination, Asset Management, Benefits Management, Communication, Crisis Management, Critical Thinking, Digital Technology, Digital Transformation, Healthcare Innovation, Information Technology Operations, Management System Development, Microsoft Teams, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC), Veterinary Medicine 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: 06/17/2026 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Responsibilities

Responsible for authoring and maintaining high-quality controlled documentation, including SOPs and validation deliverables (IQ/OQ/PQ) for the Empower CDS platform. Leads validation efforts to ensure compliance with FDA 21 CFR Part 11 and data integrity standards in GxP environments.