Senior CSV/CSA Validation Lead - GxP & Digital Transformation

Prothya Biosolutions; Amsterdam; On-site; EUR 59,000 - 85,000; Full time

Benefits offered by this job

Flexible hours

Part-time option

Pension plan

Travel reimbursement

Training budget

Job summary

Prothya Biosolutions is seeking a Validation Specialist IT (CSV/CSA) to lead validation and compliance activities for GxP-regulated systems and digital transformation initiatives across the company.

You will define validation strategies, ensure regulatory compliance, and provide leadership across project lifecycles, working with Quality, IT, Engineering, Manufacturing, and external partners. Strong knowledge of GAMP 5, CSA principles, and Data Integrity is essential.

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Information Technology, Computer Science, or related discipline.
• Validation, GAMP, CSV, CSA, or Quality-related certifications are advantageous.
• >8 years of relevant experience in Computer System Validation, Compliance, Quality Systems, or Validation Engineering, including leadership responsibilities.

Responsibilities

• Define and execute risk-based validation strategies for GxP-relevant systems and projects aligned with established CSV/CSA frameworks, standards, and procedures.
• Ensure compliance with GxP, Data Integrity, EU GMP Annex 11, FDA 21 CFR Part 11, and company procedures.
• Lead validation activities for system implementations, upgrades, integrations, and digital transformation initiatives.
• Review business requirements, functional specifications, configurations, and system designs from a validation perspective.
• Author, review, and approve validation deliverables, including Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports.

Skills

CSV leadership

GxP compliance

Data integrity

Risk-based decisions

Audit readiness

Stakeholder mgmt

Leadership

Technical writing

Education

Bachelor's or Master's in Engineering, Life Sciences, IT or CS

Validation/CSV/CSA certifications advantageous

Tools

SAP

MasterControl

MES

LIMS

QMS

Workflow platforms

Job description

Prothya Biosolutions is seeking a Validation Specialist IT (CSV/CSA) to lead validation and compliance activities for GxP-regulated systems and digital transformation initiatives across the company.

You will define validation strategies, ensure regulatory compliance, and provide leadership across project lifecycles, working with Quality, IT, Engineering, Manufacturing, and external partners. Strong knowledge of GAMP 5, CSA principles, and Data Integrity is essential.