Business System Validation Senior Specialist

MSD

Województwo mazowieckie

Hybrid

PLN 350,000 - 550,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Merck & Co. is seeking a senior validation leader to drive end-to-end validation across multiple system releases in a regulated environment. You will develop strategies, perform risk assessments, and oversee end-to-end test execution with cross-functional teams.

You will ensure traceability, lead RCA/CAPA activities, and provide expert reviews for validation deliverables. The role emphasizes SOP compliance, KPI monitoring, audits, and mentorship of junior staff.

Qualifications

Non-Degree with a minimum of 8 years of experience in System Validation or Testing Lead role.
Associate's Degree with a minimum of 7 years of experience in System Validation or Testing Lead role.
Bachelor's Degree with minimum of 5 years’ experience in System Validation or Testing Lead role.
Advanced Degree (Masters or Doctorate) with minimum of 2 years’ experience in System Validation or Testing Lead role.

Responsibilities

Lead end-to-end validation activities across multiple system releases with end users.
Develop validation strategies, risk assessments and test approaches for large-scale implementations.
Support cross-functional readiness planning by evaluating validation impacts of new features and platform releases.
Oversee test execution and defect management across multiple systems; escalate risks as needed.
Ensure traceability from requirements to evidence; identify gaps and drive remediation.
Lead root cause analysis (RCA) and CAPA activities for testing issues and drive improvements.
Provide expert review and final approval for validation deliverables (plans, scripts, summaries).
Drive SOP adherence and regulatory requirements; help harmonize validation processes and templates.
Monitor KPIs; drive continuous improvement for quality, efficiency, and audit readiness.
Act as validation SME during audits and inspections; prepare documentation and respond to auditors.
Mentor junior validation staff with training and guidance.

Skills

Adaptability

CAPA Management

Clinical Data Management

Clinical Research

Code of Federal Regulations Title 21

Communication

Continuous Improvement Techniques

Data Analysis

Data Quality Assurance

Data Reporting

Data Review

Data Validation

Defects Management

Enterprise Leadership

Good Clinical Practice (GCP)

Inspection Readiness

Key Metrics

KPI Improvement

Medical Terminology

Project Coordination

Risk-Based Testing

System Implementations

System Validation

Teamwork

Education

Non-Degree with 8+ years experience

Associate's Degree with 7+ years experience

Bachelor's Degree with 5+ years experience

Advanced Degree (Masters/Doctorate) with 2+ years experience

Tools

Test management tools

Automation platforms

Job description

Responsibilities

Validation planning, strategy & readiness
Lead end-to-end execution of complex system validation activities with end users across multiple system releases, ensuring alignment with program-level requirements, platform standards, and regulatory expectations
Develop advanced validation strategies, risk assessments, coverage models, and test approaches that support large-scale system implementations and cross-functional platform initiatives
Support cross-functional system readiness planning by evaluating validation impacts of new features, integrations, platform releases, automation workflows
Test execution, defect management & issue resolution - Oversee end-to-end test execution for multiple systems or releases, proactively managing issue resolution, escalating risks, and ensuring timely delivery of validation milestones
Ensure comprehensive traceability across requirements, design specifications, test cases, and objective evidence throughout the validation lifecycle; identify gaps and drive remediation
Lead root cause analysis (RCA) and corrective/preventive action (CAPA) activities for complex issues identified during testing; guide teams on risk mitigation and quality improvements
Documentation, compliance & continuous improvement – Provide expert review, guidance, and final approval for validation deliverables across the validation lifecycle (e.g., validation plans, test plans, test scripts, test summaries)
Drive adherence to Standard Operating Procedures (SOPs) and regulatory requirements, and contribute to authoring, updating, and harmonizing validation-related processes, templates, and standards
Monitor and report validation KPIs (Key Performance Indicators) across projects, identify systemic issues, and lead continuous improvement efforts to enhance validation quality, efficiency and audit and inspection readiness
Serve as a validation subject matter expert during audits and inspections by preparing and presenting validation packages, responding to auditor questions, and ensuring availability of complete, traceable documentation
Mentor junior validation staff by providing training, technical guidance, and quality oversight to ensure consistent execution of validation best practices

Technical skills

Deep understanding of compliance and documentation standards, (e.g., GxP, 21 CFR Part 11, and audit traceability practices)
Deep knowledge of validation lifecycle management, risk-based testing, and regulatory compliance frameworks
Proficiency in enterprise test management tools and automation platforms
Experience in implementing AI-augmented validation frameworks and model governance practices

Non‑Technical skills

Lead day-to-day activities; drive issue triage to closure; coordinate stakeholders
Mentor junior analysts on tools, checks, documentation quality and best practices
Prioritize independently; Escalate with context, impact, and recommendation
Translate technical topics for non-technical stakeholders; gain alignment on trade-offs
Manage difficult conversations constructively; negotiate timelines/quality expectations
Deliver crisp status, decisions and blockers; maintain decision logs

Enterprise Leadership Skills

Decision Making | Identify and understand problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information; solve complex problems and apply knowledge of business challenges; able to weigh multiple options and implications
Motivation & Inspiration | Communicate effectively, promote teamwork and open discussion, effectively communicate and engage / motivate teammates; inspire others toward higher levels of performance aligned with organization's Purpose and Strategic Framework
Coaching & Development | Build self-insight, demonstrate awareness of own strengths and development needs as well as impact of own behavior on others; modify behavior based on self-awareness to improve impact, serve as a resource for colleagues, coaches and guide others

Qualifications & experience

Non-Degree with a minimum of 8 years of experience working in relevant field for associated job description (System Validation or Testing Lead role)

OR [Minimum preferred] Associate's Degree with a minimum of 7 years of experience working in relevant field for associated job description (System Validation or Testing Lead role)

OR Bachelor's Degree with minimum of 5 years’ experience working in relevant field for associated job description (System Validation or Testing Lead role)

OR Advanced Degree (Masters or Doctorate) with minimum of 2 years’ experience working in relevant field for associated job description (System Validation or Testing Lead role)

Additional location(s)

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

Employee Information

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