Specialist, CDS & SDMS, Validation

Merck; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Merck Hyderabad seeks a Junior Technical Writer for Waters Empower CDS and SDMS documentation. The role emphasizes SOPs, work instructions, and validation records, aligned with GxP and data integrity. You will collaborate with technical teams to gather information and maintain documentation under guidance.

The ideal candidate has a degree in a relevant field and 3+ years of software experience, with familiarity in SDLC and CSA processes. Fluency in English and strong communication are essential.

Qualifications

• Bachelor's degree or equivalent in a Pharmaceutical, Scientific, Technology, Engineering, or Mathematics field.
• 3+ years of software experience.
• Familiarity with GxP, data integrity, and controlled documentation practices for Empower CDS.

Responsibilities

• Draft, edit, and format clear documents following templates, version control, and internal standards.
• Understand SDLC activities and Computer System Assurance (CSA).
• Gather information from SMEs, incorporate feedback, and learn Empower systems and regulated environments.
• Experience with Waters Empower CDS and NuGenesis SDMS preferred.
• Familiar with testing tools and methods such as JIRA and Microsoft Teams.
• Demonstrate strong analytical, critical thinking, and problem-solving skills; attention to detail.
• Communicate effectively in English and collaborate with global teams.

Skills

SOP

IQ/OQ/PQ

GxP

CSV

Waters Empower CDS

NuGenesis SDMS

FDA 21 CFR

English communication

Education

Bachelor's degree or equivalent

Tools

JIRA

Microsoft Teams

Job description

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:

A Junior Technical Writer for the Waters Empower CDS platform supports the creation, editing, and maintenance of documentation such as SOPs, work instructions, and validation records. They work under guidance to ensure documents align with GxP and data integrity requirements while assisting with formatting, version control, and document management processes. This role collaborates with technical teams to gather information, incorporate feedback, and build foundational knowledge of Empower and regulated documentation practices.

What you should have :

• Bachelor's degree or equivalent and a minimum of 1 years making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field.
• 3 + years of software Experience.

Primary Skills:

• SOP, IQ/ OQ/ PQ, GxP, computer system Validation(CSV), Waters Empower CDS and NuGenesis SDMS, FDA 21
• Basic understanding of GxP principles, data integrity, and document control practices, with exposure to creating and maintaining SOPs and work instructions for the Empower CDS platform.

What you will do:

• You will to draft, edit, and format clear, accurate documents while following templates, version control processes, and internal standards.
• Have good understanding of System Development Lifecycle (SDLC) activities and Computer System Assurance (CSA)
• Strong communication skills with the ability to gather information from SMEs, incorporate feedback, and quickly build knowledge of Empower systems and regulated environments.
• Experience in Waters Empower CDS and NuGenesis SDMS preferred.
• Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc.
• Strong analytic, critical thinking and problem-solving skills
• Attention to detail.
• 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.

Required Skills:

• Animal Vaccination
• Asset Management
• Benefits Management
• Critical Thinking
• Digital Technology
• Digital Transformation
• Document Controls
• GxP Validation
• Healthcare Innovation
• Information C