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Merck

Business System Validation Associate Specialist

  • POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center)
  • Full-time
  • Posted
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Skills

  • Compliance
  • Leadership

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 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:

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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.