Business System Validation Associate Specialist

Merck; Województwo mazowieckie; On-site; PLN 90,000 - 130,000; Full time

Job summary

Merck's Global Data Management & Standards (GDMS) Data Integration and Automation team seeks a Business System Validation Associate Specialist to execute and document validation activities ensuring data quality, system integrity, and regulatory compliance across data pipelines and automation workflows.

You will perform study-specific validation tests, maintain audit-ready documentation, and contribute to validation summary reports, collaborating with cross-functional partners to support clinical

Qualifications

• Non-Degree with minimum 2 years of experience in validation/testing role
• Associate's Degree with minimum 1 year in validation/testing role
• Bachelor's or Advanced Degree with prior relevant field experience (preferred)
• Experience with GxP, CSV and regulatory guidelines is preferred

Responsibilities

• Validation planning, strategy and readiness and data integrity checks across data pipelines and automation workflows
• Test execution, defect management and retesting per established procedures; participate in AI-testing and automation pilots
• Documentation, compliance and continuous improvement; prepare validation summary reports and maintain audit-ready documentation

Skills

Adaptability

Analytical Problem Solving

Data Integrity

Data Validation

Data Privacy

Education

Bachelor's Degree in a relevant field

Associate's Degree

Non-Degree with 2+ years experience

Tools

Test Management Tools

Clinical Data Management Systems

Job description

Are you passionate about ensuring data integrity, regulatory compliance, and the successful delivery of business-critical systems? Join our team and play a key role in validating innovative data integration and automation solutions that support high-quality clinical and business operations.

The Business System Validation Associate Specialist, GDMS Data Integration and Automation is responsible for executing and documenting validation activities to ensure data quality, system integrity, and regulatory compliance within GDMS (Global Data Management & Standards). This includes performing standard and study-specific validation tests, maintaining audit-ready documentation, and preparing validation summary reports.

Responsibilities

• Validation planning, strategy & readiness – Perform data integrity and consistency checks across data pipelines, integrations, and automation workflows.
• Test execution, defect management, & issue resolution – Execute standard and study-specific validation tests in alignment with established protocols and test scripts. Log, track, and retest defects in accordance with defect management procedures and timelines. Participate in AI-testing and automation pilots, ensuring adherence to validation standards and documentation practices.
• Documentation, compliance & continuous improvement – Record detailed test results, maintain traceable evidence, and ensure audit-ready documentation. Prepare and maintain validation summary reports, ensuring completeness and compliance with internal and regulatory standards.

Technical skills

• Familiarity with clinical data management systems / platforms, data integration environments, and cloud computing platforms
• Proficiency with GxP, computer system validation (CSV), and other regulatory guidelines
• System Development Lifecycle Management / computer system validation knowledge
• Good documentation and testing practices preferred
• Experience or familiarity with test management tools

Non-Technical skills

• Communicate effectively (oral/written) with technical and business partners and external vendors; adapt style to audience and able to translate technical topics into plain language
• Prioritize tasks, meet deadlines, maintain clean documentation
• Provide clear, timely updates; ask clarifying questions; write concise notes/status
• Establish positive working relationships across functions; receptive to and incorporate feedback quickly
• Apply basic structured thinking to resolve straightforward issues; know when to elevate
• Eager to learn new processes/technologies
• Strong attention to detail; follow SOPs and respect data privacy/compliance norms

Enterprise Leadership Skills

• Execution Excellence | Reliably complete routine, structured work using existing procedures; prompt, accurate, and compliant in execution; take action to achieve results beyond what is required
• Talent Growth | Focus on self-development, openness to feedback, and quickly building skills; embrace continuous learning and actively identify new areas for growth
• Diversity, Equity, & Inclusion | Respect and appreciate diverse perspectives; serve as a good team citizen that contributes to overall team effectiveness; value differences and work effectively with individuals of diverse backgrounds

Qualifications & experience

Non-Degree with a minimum of 2 years of experience working in relevant field validation / testing role

OR

[Minimum preferred] Associate's Degree with a minimum of 1 year experience working in relevant field validation / testing role

OR

Bachelor's Degree or Advanced Degree (Masters or Doctorate) with prior experience in relevant field preferred (not required)

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

Required Skills

• Adaptability
• Adaptability
• Analytical Problem Solving
• Clinical Data Cleaning
• Clinical Data Management
• Clinical Information Systems
• Computer System Validation (CSV)
• Data Analysis
• Data Documentation
• Data Entry
• Data Integrity
• Data Pipelines
• Data Privacy
• Data Processing
• Data Reporting
• Data Review
• Data Validation
• Data Visualization
• Defects Management
• Enterprise Leadership
• Good Clinical Practice (GCP)
• Openness to Change
• Personal Development
• Prioritization
• Regulatory Compliance {+ 9 more}