Senior CSV/CSA Validation Lead - Flexible IT Compliance

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

Benefits offered by this job

Full-time 40h

Salary €5,290.02–€7,604.37 gross per月

Holiday allowance 8.33%

13th month

30 holiday days

Training budget €2,100 every 3 years

Travel expense coverage

Pension plan

Job summary

Prothya Biosolutions in the Netherlands is seeking a Senior Validation Specialist IT (CSV/CSA) to lead validation and compliance activities for GxP-regulated systems, digital transformation projects, and IT/OT integrations across the organization.

You will define strategies, ensure Data Integrity and regulatory compliance (EU GMP Annex 11, FDA 21 CFR Part 11), review validation deliverables, mentor teams, and collaborate with Quality, IT, Engineering and Manufacturing to drive audit readiness

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, IT, 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 CSV/CSA frameworks.
• Ensure compliance with GxP, Data Integrity, EU GMP Annex 11, FDA 21 CFR Part 11, and company procedures.
• Lead system validation activities for IT/OT environments and digital transformations.
• Review requirements, configurations, and designs from a validation perspective.
• Provide validation oversight across project plans and delivery activities.
• Coach and mentor teams on validation best practices and coordinate with vendors.

Skills

CSV/CSA expertise

GxP compliance

Data Integrity

Risk-based decision making

Audit readiness

Leadership

Technical writing

Education

Bachelor's or Master's degree in Engineering, Life Sciences, IT, or related field

Validation, GAMP, CSV/CSA certifications advantageous

8+ years of relevant experience

Tools

SAP

MasterControl

MES

LIMS

QMS

Workflow platforms

Job description

Prothya Biosolutions in the Netherlands is seeking a Senior Validation Specialist IT (CSV/CSA) to lead validation and compliance activities for GxP-regulated systems, digital transformation projects, and IT/OT integrations across the organization.

You will define strategies, ensure Data Integrity and regulatory compliance (EU GMP Annex 11, FDA 21 CFR Part 11), review validation deliverables, mentor teams, and collaborate with Quality, IT, Engineering and Manufacturing to drive audit readiness