Business System Validation Specialist

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

Job summary

Merck in Poland seeks a Business System Validation Specialist, GDMS Data Integration and Automation, to lead validation activities ensuring data integrity, regulatory compliance, and timely delivery of critical systems.

You will plan, execute, and document validation across studies, support audits, and collaborate with Product Owners, QA, and Engineering to drive continuous improvement in validation processes and evidence management.

Qualifications

• 4+ years in validation/testing role
• Experience with GxP and 21 CFR Part 11
• Experience with clinical data management systems
• Knowledge of SDLC and system validation
• Audits/inspections support experience

Responsibilities

• Execute standard and study-specific validation activities across systems per protocol and regulatory expectations
• Develop validation strategies and risk-based test coverage models for releases and milestones
• Maintain validation documentation (Test Plans, TRMs, Test Scripts, Defect Logs, Test Summaries)
• Monitor test execution, track defects, and coordinate issue resolution with cross-functional teams
• Contribute to RCA and CAPA for issues identified during testing
• Support internal and external audits/inspections with validation evidence

Skills

Data validation

Data integrity

Regulatory compliance

SDLC management

AI testing exposure

Education

Bachelor's degree

Associate's degree

Advanced degree (Masters or Doctorate)

Tools

Power BI

Job description

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 Specialist, GDMS Data Integration and Automation is responsible for supervising the execution of system validation activities to ensure data integrity, regulatory compliance, and operational excellence. This includes managing testing, supervising test planning and documentation, and monitoring issue resolution to ensure timely delivery.

Responsibilities

Validation planning, strategy, & readiness

• Responsible for execution of standard and study-specific validation activities across assigned systems, ensuring alignment with protocol requirements, technical specifications, and regulatory expectations
• Assist in the creation of validation strategies and risk-based test coverage models to support system releases and project milestones
• Support the development and maintenance of validation documentation (e.g., Test Plans, Requirements Traceability Matrices, Test Scripts, Defect Logs, and Test Summaries)

Test execution, defect management, & issue resolution

• Monitor progress of test execution, track defects, manage issue resolution, and ensure timely completion of deliverables with cross-functional partners (e.g., Product Owners, System subject matter experts, QA, and Engineering teams)
• Perform detailed test execution for functional, integration, and user acceptance testing (UAT), documenting objective evidence in accordance with established procedures
• Participate in root cause analysis (RCA) activities and contribute to corrective and preventive action (CAPA) recommendations for issues identified during testing

Documentation, compliance, & continuous improvement

• Ensure accuracy, completeness, and inspection readiness of validation packages by adhering to Standard Operating Procedures (SOPs) and validation lifecycle requirements
• Support system readiness assessments by evaluating requirements, technical impacts, and validation dependencies across integrations and upstream/downstream systems
• Contribute to continuous improvement initiatives by identifying opportunities to streamline validation processes, templates, and evidence management practices
• Assist in internal and external audits/inspections by preparing validation documentation, retrieving required evidence, and supporting auditor/inspector inquiries

Technical skills

• Proficiency in clinical data management systems / platforms, data integration environments, and cloud computing platforms
• Understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices)
• Experience working with SDLC management/ system validation
• Exposure to AI testing or automation frameworks and understanding of their validation requirements
• Basic proficiency in metrics and reporting tools (e.g., Power BI)

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
• Work independently with guidance; proactively flag risks and proposes options
• Collaborate smoothly across functions; facilitate small working sessions; follow through on action items
• Able to handle multiple tasks and priorities; maintaining focus on critical path
• Triage issues using data; document assumptions, decisions, and next steps

Enterprise Leadership Skills

• Execution Excellence | Focus on self-development, openness to feedback, and quickly building skills; embrace continuous learning and actively identify new areas for growth
• Decision Making | Identify and analyze problems by interpreting qualitative and quantitative information, select best course of action, and make timely decisions while considering tradeoffs; optimize probable consequences
• Networking & Partnership | Build knowledge of the company, processes, clients, and customers; work across functions and collaborate effectively; leverage relationships within and across work groups to achieve results

Qualifications & experience

• Non-Degree with a minimum of 4 years of experience working in relevant field validation / testing role
• OR
• [Minimum preferred] Associate's Degree with a minimum of 3 years' experience working in relevant field validation / testing role
• OR
• Bachelor's Degree with minimum of 2 years' experience working in relevant field validation / testing role
• OR
• Advanced Degree (Masters or Doctorate) with prior experience in relevant field preferred (not required)

Additional location(s) Compensation Information:

Required Skills:

Clinical Data Cleaning, Clinical Data Management, Customer-Focused, Data Analysis, Database Development, Data Processing, Data Quality Assurance, Data Review, Data Validation, Data Visualization, Trade-Off Anal