Hybrid: Data Validation & Compliance Specialist

MSD; Warszawa; Hybrid; PLN 90,000 - 130,000; Full time

Job summary

Merck & Co., Inc. in Warsaw is seeking a Business System Validation Specialist to supervise validation activities for data integration and automation solutions that support high-quality clinical and business operations.

You will manage test planning, execution, and documentation, maintaining evidence in line with SOPs, and collaborate with Product Owners, QA, and Engineering to ensure regulatory readiness and timely delivery. Experience with GxP, 21 CFR Part 11, and audit readiness is valued.

Qualifications

• Minimum 4 years of validation/testing experience in a relevant field (non-degree).
• 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 preferred, with prior relevant experience (not required).

Responsibilities

• Validation planning, strategy, & readiness for assigned systems.
• Test execution, defect management, and issue resolution with cross-functional partners.
• Documentation, compliance, and inspection readiness of validation packages.
• Support system readiness assessments and audits/inspections.

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

Education

Non-Degree with 4+ years experience

Associate's Degree

Bachelor's Degree

Advanced Degree (Masters/PhD)

Job description

Merck & Co., Inc. in Warsaw is seeking a Business System Validation Specialist to supervise validation activities for data integration and automation solutions that support high-quality clinical and business operations.

You will manage test planning, execution, and documentation, maintaining evidence in line with SOPs, and collaborate with Product Owners, QA, and Engineering to ensure regulatory readiness and timely delivery. Experience with GxP, 21 CFR Part 11, and audit readiness is valued.