Senior Specialist, Lab Execution System, Business Analyst

MSD; Hyderabad; Hybrid; INR 1,500,000 - 2,500,000; Full time

Job summary

Merck & Co., Inc. in Hyderabad is seeking a Lead IT Business Analyst to support SDLC development and GMP validation of the Biovia OneLab platform for QC labs.

This role will partner with laboratory, quality, IT and vendor stakeholders to define requirements and ensure regulatory compliance in a controlled environment. You will help mentor team members, drive documentation standards, and support system changes while ensuring data integrity and compliance with FDA 21 CFR Part 11.

Qualifications

• 7–11 years proven experience as a Business Analyst/Technical Analyst in the regulated GxP pharma lab environment.
• Strong understanding of regulatory requirements and compliance in the pharmaceutical industry.
• Experience with the Laboratory Information Systems (LIMS) or Laboratory Execution System (LES).
• Experience supporting large-scale, global, complex projects, associated with digital transformation/optimization initiatives.
• Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc.
• Technical skills in light coding, database querying (e.g., SQL), and system configurations.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills to effectively engage with stakeholders.
• Ability to work independently and as part of a cross-functional team and manage multiple priorities in a dynamic environment.
• Experience supporting large-scale, global, complex projects, associated with digital transformation/optimization initiatives.
• Experience with Computer System Assurance (CSA).

Responsibilities

• Elicit business requirements for QC Lab operations.
• Conduct stakeholder interviews and working sessions to gather insights and clarify needs.
• Analyze and translate business requirements into functional and technical specifications for the selected technology.
• Collaborate with project teams to ensure alignment in the design and implementation of systems and processes.
• Contribute to the development of detailed project plans.
• Develop and maintain comprehensive project documentation, including requirement specifications, use cases, and user testing.
• Facilitate discussions to ensure stakeholder understanding and agreement on requirements and design.
• Conduct gap analysis to identify discrepancies between current processes and desired outcomes.
• Support the design and implementation of solutions that comply with regulatory standards in the GxP environment.
• Assist in user acceptance testing (UAT) to ensure that solutions meet business requirements and operational needs.
• Provide training and ongoing support to end-users on new systems and processes.
• Perform light coding, database querying, and system configurations as needed to support project goals.
• Develop SDLC documents (Process Maps, Workflows, QAP, RS, UAT, QASR, SOPs, etc.)

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. Join a team that is passionate about using data, analytics, and insights to drive decision-making and create 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 ensure we can manage and improve each location, from investing in the 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. 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

As part of our global Lab Transformation effort, we are seeking a Lead IT Business Analyst to support SDLC development and GMP validation of the Biovia OneLab platform for Quality Control labs. This role will partner with laboratory, quality, IT, and vendor stakeholders to define requirements, support solution delivery, and ensure the platform meets business, compliance, and validation needs in a regulated environment. The Lead IT Business Analyst will help ensure compliance with FDA 21 CFR Part 11 and data integrity standards, while collaborating 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 the Biovia OneLab platform.

What Will You Do In This Role

• Elicit business requirements for QC Lab operations.
• Conduct stakeholder interviews and working sessions to gather insights and clarify needs.
• Analyze and translate business requirements into functional and technical specifications for the selected technology.
• Collaborate with project teams to ensure alignment in the design and implementation of systems and processes.
• Contribute to the development of detailed project plans.
• Develop and maintain comprehensive project documentation, including requirement specifications, use cases, and user testing.
• Facilitate discussions to ensure stakeholder understanding and agreement on requirements and design.
• Conduct gap analysis to identify discrepancies between current processes and desired outcomes.
• Support the design and implementation of solutions that comply with regulatory standards in the GxP environment.
• Assist in user acceptance testing (UAT) to ensure that solutions meet business requirements and operational needs.
• Provide training and ongoing support to end-users on new systems and processes.
• Perform light coding, database querying, and system configurations as needed to support project goals.
• Develop SDLC documents (Process Maps, Workflows, QAP, RS, UAT, QASR, SOPs, etc.)

What Should You Have

• 7 - 11 years Proven experience as a Business Analyst / Technical Analyst in the regulated GxP pharma lab environment.
• Strong understanding of regulatory requirements and compliance in the pharmaceutical industry.
• Experience with the Laboratory Information Systems (LIMS) or Laboratory Execution System (LES).
• Experience supporting large-scale, global, complex projects, associated with digital transformation/optimization initiatives.
• Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc.
• Technical skills in light coding, database querying (e.g., SQL), and system configurations.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills to effectively engage with stakeholders.
• Ability to work independently and as part of a cross-functional team and manage multiple priorities in a dynamic environment.
• Experience supporting large-scale, global, complex projects, associated with digital transformation/optimization initiatives.
• Experience with Computer System Assurance (CSA).

Nice to haves

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Information Technology).
• Experience with Agile methodologies and project management tools.
• Experience with system-system integrations and instrument integrations.
• Experience with the Biovia OneLab product
• Experience with MODA, Scitara, LabWare, LabX
• Experience with Appian.
• Knowledge of data analysis and visualization tools.

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

Data Engineering, Data Visualization, Design Applications, Software Configurations, Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, System Integration, Testing

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

Flexible Work Arrangements

Hybrid

Job Posting End Date

08/31/2026

Requisition ID

R400164