Spclst , Scitara Tester

Job Description

Tester Job Description – Digital Quality & Lab (DQ&L) Instrument & Integration Tester
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 ca*n* 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:
We have an exciting opportunity for a Technical Product Management - Digital Quality & Lab (DQ&L) Instrument & Integration Tester.
Our Digital Quality & Lab Instrument & Material Management team operates as a technology product owner and business partner, proposing innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and platforms that increase productivity, enable innovation, and ensure compliance across laboratory and manufacturing environments.
The DQ&L Instrument & Integration Tester will support the authoring and execution of testing activities for the integration of analytical and analytical ancillary instrument systems. This role ensures solutions are verified and validated through documented testing aligned to intended use.
This position focuses on integration testing of instruments and systems, ensuring that data flows, transformations, and workflows across platforms (e.g., Scitara DLX, Empower, BIOVIA, MODA-EM, LabX, Labware LIMS) operate as intended and meet GxP, data integrity, and Computer System Assurance (CSA) expectations. The Tester partners closely with Business Analysts and Technical Analysts, who define
requirements and design solutions, while the Tester ensures those outputs are effectively verified through robust, risk-based testing.
Bring energy, knowledge, innovation to carry out the following:
• Collaborate with local and global business partners, including Business Analysts and Technical Analysts, to understand requirements and system design to support test development and execution
• Support project completion in line with established timescales through the authoring and execution of SDLC testing activities, ensuring alignment to cross-functional deliverables
• Author and execute test cases, scripts, and datasets aligned to business requirements, functional and configuration specifications, and integration workflows
• Execute testing across functional workflows, instrument-to-system and system-to-system integrations, and end-to-end workflows spanning multiple platforms
• Validate data exchange, transformation, and orchestration, ensuring accuracy, completeness, and preservation of data, and alignment to intended system behavior and business processes
• Develop and maintain complete and auditable traceability between requirements, test cases, execution results, and defects, ensuring clear linkage to intended use
• Identify, document, classify, and manage defects, ensuring issues are:
o Reproducible and clearly described
o Assessed and prioritized based on risk to compliance, data integrity, and business operations
o Resolved and verified through re-testing
• Author and execute testing deliverables in support of validation, including test protocols/scripts, execution evidence, and defect or deviation documentation, providing evidence supporting fitness for intended use
• Ensure all testing aligns with Computer System Assurance (CSA) principles (risk-based approach), GxP expectations, 21 CFR Part 11, EU Annex 11, and Data Integrity principles (ALCOA+)
• Participate in requirements and design reviews to confirm solutions are testable and verifiable, escalating gaps or ambiguities as needed
• Validate integration patterns including API-based, file-based, and OPC UA integrations supporting instrument connectivity and orchestration workflows, ensuring:
o Data mappings and transformations are correct
o Exception handling and error conditions behave as expected
o Logging and traceability support audit and troubleshooting requirements
• Identify opportunities to improve testing efficiency, standardization, and reuse of test assets across platforms and programs.

What skills you will need:
In order to excel in this role, you will more than likely have:
• Degree in life science (e.g., microbiology, chemistry, biochemistry, biotechnology), IT, or engineering discipline
• Strong background in pharmaceutical quality, laboratory, or manufacturing operations
• Hands-on experience supporting test design, execution, and defect management for laboratory instrumentation systems and integrations
• Broad understanding of computerized systems, IT, SDLC, and qualification principles, including Computer System Assurance (CSA)
• In-depth knowledge of data integrity regulations and requirements, including FDA 21 CFR Part 11 and EU Annex 11, with demonstrated application
• Demonstrated experience validating instrument data flows, system integrations (API, file-based, OPC UA), and data transformations and standardization concepts (e.g., FAIR data principles)
• Strong analytical and problem-solving skills with high attention to detail in test design and execution
• Clear and professional communication skills with the ability to explain technical concepts to support cross-functional collaboration
• Ability to work independently and collaboratively within a global, cross- functional team environment
• Prior experience with direct use of laboratory instrumentation and digital lab systems
• Familiarity with digital validation systems (e.g., Kneat eVal, X-Ray, TOSCA, Robot Framework)
• Experience with integration platforms (e.g., Scitara DLX) and understanding of modern integration patterns preferred
• Preferred certification in CSQE
• Demonstrated interest in continuous improvement and digital transformation

What success looks like:
First 6 months
• Authors and executes traceable, testable test cases aligned to requirements and system design with minimal oversight across multiple instrument integrations
• Produces clear, audit-ready testing documentation and execution evidence
• Applies risk-based testing aligned to CSA principles, demonstrating understanding of GxP, Part 11 / Annex 11, and data integrity expectations
• Identifies and documents high-quality, reproducible defects with appropriate business and technical context
• Demonstrates ability to validate functional workflows and foundational integration behavior, including data flow and system interactions
• Collaborates effectively with Business Analysts and Technical Analysts to ensure requirements are testable and solutions are verifiable

12 months
• Independently owns testing activities for features or releases, including planning, design, execution, and defect resolution
• Maintains complete and defensible traceability from requirements through test execution and closure
• Consistently produces inspection-ready outputs aligned to CSA, GxP, and data integrity expectations
• Demonstrates strong capability validating complex instrument integrations, end-to-end workflows, and data transformations
• Identifies systemic quality issues and contributes improvements to testing practices and upstream requirements or design clarity
• Contributes to reduction of defects entering User Acceptance Testing (UAT) and production environments
• Recognized by cross-functional stakeholders as a trusted quality contributor balancing compliance
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.

#HYDIT2025

Required Skills:

Asset Management, Benefits Management, Biochemistry, Biotechnology, Data Integrity, Foster Innovation, Life Science, Management System Development, Manufacturing Environments, Microbiology, Operational Acceptance Testing (OAT), Pharmaceutical Process Engineering, Product Management, Requirements Management, Risk-Based Testing, Stakeholder Relationship Management, Strategic Planning, System Designs, System Integration, User Acceptance Testing (UAT)

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:

Not Applicable

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. **