Validation Engineer IT

Prothya Biosolutions; Amsterdam; On-site; EUR 52,000 - 75,000; Full time

Benefits offered by this job

8.33? holiday allowance

13th month

30 holiday days

Training budget

Travel expense reimbursement

Pension plan

Job summary

Prothya Biosolutions in the Netherlands seeks a Validation Engineer IT to lead and execute CSV/CSA activities across GxP systems and IT/OT environments. You will ensure compliance with EU GMP Annex 11 and FDA 21 CFR Part 11, and deliver inspection-ready documentation.

Join a cross-functional team spanning Quality, IT, Engineering and Manufacturing to advance digital transformation projects while maintaining rigorous validation standards and data integrity.

Qualifications

• Bachelor's degree in a relevant field.
• Certifications in Validation, GAMP, CSV/CSA are advantageous.
• >5 years in Computer System Validation, Compliance, Quality Systems, or Validation Engineering.

Responsibilities

• Execute CSV/CSA activities for GxP-relevant systems.
• Ensure compliance with GxP, Data Integrity, Annex 11 and Part 11.
• Prepare validation deliverables (IQ/OQ/PQ, test scripts, SARs).
• Support audits, inspections, and change control activities.
• Collaborate with Quality, IT, Engineering, Manufacturing and vendors.

Skills

CSV/CSA expertise

GxP compliance

Validation documentation

Risk assessment

Audit readiness

Technical writing

Education

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

Tools

ERP

MES

LIMS

QMS

Workflow platforms

Job description

As our Validation Engineer IT you will support validation and compliance activities for GxP-regulated systems, digital transformation initiatives, equipment, infrastructure, and system integration projects across Prothya. Your role is responsible for executing validation activities throughout the project and system lifecycle, ensuring solutions comply with established validation frameworks, CSV/CSA principles, Data Integrity requirements, and applicable regulations. Working closely with Quality, IT, Engineering, Manufacturing, and project teams, you support the successful delivery of compliant and inspection-ready systems.

Key Responsibilities:

1. Validation Execution & Compliance

• Execute risk-based CSV/CSA activities for GxP-relevant systems and projects in accordance with established validation frameworks, standards, and procedures.
• Ensure compliance with GxP, Data Integrity, EU GMP Annex 11, FDA 21 CFR Part 11, and company procedures.
• Support audits, inspections, and compliance assessments.

2. System & Project Validation

• Support validation activities for system implementations, upgrades, integrations, and digital transformation initiatives.
• Review requirements, specifications, configurations, and system documentation from a validation perspective.
• Execute testing activities and support defect management and resolution.
• Support validation activities for both IT and OT systems where applicable.

3. Validation Documentation & Lifecycle Management

• Prepare and maintain validation deliverables, including Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports.
• Ensure validation documentation remains complete, accurate, traceable, and inspection-ready.

4. Quality & Risk Management

• Support impact assessments and risk assessments.
• Participate in change control, deviation, CAPA, and incident management activities.
• Contribute to continuous improvement of validation processes and practices.
• Work closely with Quality, IT, Engineering, Manufacturing, and Business teams.
• Coordinate validation activities with vendors and implementation partners.
• Collaborate with Validation Managers, Lead CSV representatives, and project teams to ensure alignment with validation, compliance, and governance requirements.

Core Competencies:

• Computer System Validation (CSV) and Computer Software Assurance (CSA).
• GxP and Data Integrity compliance.
• Validation documentation and testing.
• Risk assessment and problem solving.
• Audit readiness and compliance awareness.
• Technical writing and documentation.

Your profile:

Professional/ Educational Background:

• Bachelor's degree in Engineering, Life Sciences, Information Technology, Computer Science, or a related discipline.
• Validation, GAMP, CSV, CSA, or Quality-related certifications are advantageous.
• >5 years of relevant experience in Computer System Validation, Compliance, Quality Systems, or Validation Engineering.

Functional/ Industry Experience:

• Experience in pharmaceutical, biotech, life sciences, or GMP manufacturing environments preferred.
• Knowledge of GAMP 5, CSA principles, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity requirements.
• Experience with ERP, MES, LIMS, QMS, workflow platforms, or similar regulated systems.
• Exposure to IT and/or OT validation activities is advantageous.
• Experience supporting CSV and CSA activities in regulated environments.
• Experience validating enterprise applications, manufacturing systems, or system integrations.
• Understanding of validation lifecycle management, risk assessment, change control, and compliance practices.
• Experience preparing validation documentation and executing qualification or testing activities.

Other Requirements:

• Ability to work effectively across Quality, IT, Engineering, Manufacturing, and Business functions.
• Strong attention to detail, documentation quality, compliance, and continuous improvement.
• Ability to work in international and cross-functional project teams.

Why This Role?

• Contribute to strategic digital transformation initiatives.
• Gain exposure to IT, OT, Quality, Engineering, and Manufacturing systems.
• Play a key role in ensuring compliant implementation of digital technologies.

What we offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• Salary between€ 4.702,26 and € 6.759,41 gross per month (based on full-time employment).
• 8.33% holiday allowance and a 13th month.
• 30 holiday days (based on fte).
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.