Senior Business System Validation Lead

Merck

Województwo mazowieckie

On-site

PLN 200,000 - 320,000

Full time

5 days ago

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Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Merck is seeking a Business System Validation Senior Specialist to define enterprise validation strategies and ensure compliance across data integration projects. You will oversee risk-based validation planning, test criteria, and audit-ready documentation.

You will lead end-to-end validation activities with multiple system releases, ensuring alignment with regulatory expectations, platform standards, and program requirements.

Qualifications

At least 8 years of system validation or testing leadership experience.
Experience with GxP, 21 CFR Part 11, and audit traceability.
Proven ability to lead cross-functional validation activities.
Experience with validation lifecycle management and risk-based testing.

Responsibilities

Validation planning, strategy & readiness.
Lead end-to-end validation with end users across releases.
Develop validation strategies, risk assessments and coverage models.
Support cross-functional readiness planning for new features and platforms.
Oversee test execution and CAPA activities; ensure traceability across artifacts.
Prepare validation packages for audits and inspections.

Skills

Validation leadership

Regulatory compliance

Risk assessment

Test management

Automation platforms

Education

Non-Degree with 8+ years

Associate's Degree with 7+ years

Tools

Enterprise test management tools

Automation platforms

Model governance software

Job description

You will lead end-to-end validation activities with multiple system releases, ensuring alignment with regulatory expectations, platform standards, and program requirements.

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