Specialist, Process Optimization - GMP Analyst

EyeBio; India; On-site; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck & Co., Inc., Rahway, New Jersey, USA invites a mid-level specialist in Hyderabad to lead GMP-compliant SDLC activities for our product platform and support future validation efforts. This role ensures regulatory alignment across quarterly release cycles and long-term lifecycle management.

You will coordinate with Quality, IT, and Product teams to deliver validation, documentation, and release planning while maintaining GMP standards and robust change control processes for global systems.

Qualifications

• Bachelor’s degree in CS/Eng/LS or related field.
• 3+ years GMP validation or CSV/CSA experience.
• Familiarity with Jira and Confluence.
• Knowledge of FDA/EMA/ICH guidelines.
• Strong documentation and stakeholder engagement.

Responsibilities

• Own GMP SDLC deliverables including validation documentation and testing protocols.
• Collaborate with Quality, IT, Product to ensure SDLC-SOP-09 compliance.
• Support periodic validation cycles and change control processes.
• Maintain system documentation and configuration profiles per GMP standards.
• Participate in workshops to define validation scope and resources.
• Contribute to SOP development and lifecycle sustainment for IT systems.

Skills

GMP Validation

SDLC Execution

Jira/Confluence

Regulatory Knowledge

Documentation

Education

Bachelor’s degree in CS/Engineering/Life Sciences

Tools

Jira

Confluence

Digital SDLC

Job description

Job Description

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 Centres 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 Centres 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 Centre 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 Centres.

Role Overview

We are seeking a mid-level specialist to lead and sustain GMP-compliant SDLC activities for the Our product platform and support future validation efforts for our products. This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.

What will you do in this role

• Own and execute GMP SDLC deliverables for our products, including validation documentation, testing protocols, and release planning.
• Collaborate with cross-functional teams (Quality, IT, Product) to ensure compliance with SDLC-SOP-09 and CSA methodology.
• Support periodic validation cycles and change control processes for Internal platforms.
• Maintain system documentation and configuration profiles in alignment with GMP standards.
• Participate in workshops and stakeholder sessions to define validation scope and resource needs.
• Contribute to SOP development and lifecycle sustainment for IT system administration and validation packages

What should you have

Primary skills :

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
• 3+ years of experience in GMP validation, SDLC execution, or CSV/CSA methodologies.
• Familiarity with tools such as Jira, Confluence, and Digital SDLC platforms
• Strong understanding of regulatory frameworks (FDA, EMA, ICH) and risk-based validation approaches.
• Excellent documentation, communication, and stakeholder engagement skills.

Secondary Skills:

• Experience supporting validation efforts for manufacturing intelligence platforms.
• Knowledge of SDIRA, IT Supplier Management, and automated compliance tools.
• Prior exposure to SOP authorship and lifecycle sustainment in a GMP environment.

Why Join Us?

This is a strategic role with long-term impact on our digital manufacturing platforms. You’ll be part of a high-performing team driving compliance, innovation, and operational excellence across global systems.

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 for lives, 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:

• Agile SDLC, Asset Management, Atlassian Confluence, GMP Compliance, GMP Validation, JIRA Tool, Product Management, Software Development Life Cycle (SDLC), Strategic Planning, System Designs

Preferred Skills:

• Authorship, GxPs, Manufacturing Intelligence, SOP Compliance, SOP Documentation

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Employee Status

Regular

Flexible Work Arrangements

• Hybrid

Job Posting End Date: 08/21/2026