Business System Validation Specialist

MSD; Województwo mazowieckie; Hybrid; PLN 120,000 - 200,000; Full time

Job summary

MSD is seeking a Business System Validation Specialist to supervise validation activities for data integration and automation in clinical and business operations. You will ensure data integrity, regulatory compliance, and timely delivery across validation lifecycles.

Responsibilities include planning, executing, and documenting validation efforts, supporting audits, and driving continuous improvement in validation processes and evidence management.

Qualifications

• Non-Degree with at least 4 years of validation/testing experience.
• Associate's Degree with at least 3 years experience in validation/testing.
• Bachelor's Degree with at least 2 years experience in validation/testing.
• Advanced Degree (Masters or Doctorate) with prior relevant experience preferred.

Responsibilities

• Plan validation strategies and readiness.
• Execute validation activities across systems, per protocol.
• Create and maintain validation documentation (plans, matrices, scripts).
• Monitor test execution, track defects, and manage resolutions.
• Perform functional, integration, and UAT testing with evidence.
• Contribute to RCA and CAPA for identified issues.

Skills

Data validation

Quality assurance

Regulatory compliance

SDLC validation

Education

Bachelor's Degree

Associate's Degree

Non-Degree (4+ years)

Advanced Degree

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 Analysis Preferred Skills: 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: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/14/2026 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.