Business System Validation Associate Specialist

MSD; Województwo mazowieckie; On-site; PLN 355,000 - 473,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Business System Validation Associate Specialist to validate data integration and automation solutions supporting clinical and business operations.

You will execute validation tests, maintain audit-ready documentation, and prepare validation summaries in line with GxP and CSV guidelines, collaborating with cross-functional teams and external vendors.

Qualifications

• Minimum 2 years in validation/testing in a relevant field
• Associate degree is required; bachelor’s degree preferred
• Familiarity with data management systems and regulatory guidelines is a plus

Responsibilities

• Validation planning, strategy & readiness
• Perform data integrity checks across data pipelines and automation workflows
• Execute validation tests and manage defects with timelines
• Log, track, and retest defects per procedures
• Prepare validation summary reports ensuring audit-ready documentation
• Maintain traceable evidence and compliant documentation

Skills

Data validation

GxP

Documentation

CSV

Education

Associate degree

Bachelor's degree

Tools

Test management tools

Data integration platforms

Cloud platforms

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 escalat[e]
• 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
• Associate's Degree with a minimum of 1 year experience working in relevant field validation / testing role
• Bachelor's Degree or Advanced Degree (Masters or Doctorate) with prior experience in relevant field preferred (not required)

Additional location(s)

• Rahway, NJ, USA

Employment Terms

• Employee Status: Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Hybrid Shift:
• Valid Driving License:
• Hazardous Material(s):

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

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.