Business System Validation Associate Specialist

MSD; Warszawa; Hybrid; PLN 140,000 - 200,000; Full time

Job summary

Merck & Co., Inc. in Warsaw, Poland, is hiring a Business System Validation Associate Specialist to validate data integration and automation solutions that support clinical and business operations.

The role focuses on CSV, data integrity, and regulatory compliance, with hands-on testing, documentation, and audit-ready summaries. You will plan validation activities, execute tests across data pipelines, log defects, and collaborate with cross-functional teams to ensure timely delivery and

Qualifications

• Bachelor's or higher in life sciences or related field preferred; relevant validation/testing experience required.
• Experience with CSV/CSV-like systems, data integrity checks, and audit-ready documentation.
• Familiarity with clinical data management systems, data integration environments, and regulatory guidelines (GCP, CSV).

Responsibilities

• Plan validation strategies and readiness activities for data integration and automation projects.
• Execute validation tests per protocols; log, track, and retest defects; ensure traceable evidence and audit-ready reports.
• Prepare validation summaries and collaborate with cross-functional teams to ensure compliant delivery.

Skills

Adaptability

Analytical problem solving

Data integrity

Regulatory compliance

CSV validation

Data management

Data analysis

Documentation practices

GxP

Communication

Education

Bachelor's degree in life sciences / related field

Non-Degree with 2+ years experience

Associate's degree (1+ year)

Job description

## Business System Validation Associate SpecialistApply: Hybrid: POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center): Full time: Posted Today: End Date: November 14, 2026 (14 days left to apply): R424428Job DescriptionAre 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 escalate* 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) **Additional location(s) Compensation Information:****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}**Preferred Skills:**Current Employees apply HERECurrent 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:**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.