Senior IT Validation Lead | GxP, CSV/CSA, Compliance

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

Benefits offered by this job

Flexible hours

Holiday allowance

13th month

30 holiday days

Training budget

Travel reimbursement

Commuter benefits

Pension plan

Job summary

Prothya Biosolutions in Amsterdam seeks an experienced Validation Lead to drive CSV/CSA within GMP environments. You will define and execute risk-based validation strategies for IT/OT systems and projects, ensuring alignment with EU GMP Annex 11 and data integrity.

You will integrate validation into project plans, oversee IQ/OQ/PQ, risk assessments, and traceability, and coach cross-functional teams. Engage with QA, IT, Engineering and Manufacturing to uphold high compliance standards.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, IT, CS, or related field.
• 8+ years of relevant experience in Computer System Validation, Compliance, Quality Systems, or Validation Engineering with leadership responsibilities.
• Experience in pharmaceutical, biotech, life sciences or GMP manufacturing environments; strong GAMP 5, CSA, FDA 21 CFR Part 11, EU GMP Annex 11 knowledge.

Responsibilities

• Define and execute risk-based validation strategies for GxP-relevant systems and projects aligned with CSV/CSA.
• 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 transformations.
• Provide validation oversight for IT and OT systems; review requirements, configurations, and designs from a validation perspective.
• Author, review, and approve validation deliverables (IQ/OQ/PQ, Traceability Matrices, Validation Plans, Risk Assessments).
• Coach and mentor project teams on validation best practices; coordinate with vendors and partners.
• Collaborate with Lead CSV representatives and Quality stakeholders to ensure alignment with governance.

Skills

CSV/CSA

GxP compliance

Data integrity

Risk-based decisions

Audit readiness

Stakeholder mgmt

Leadership

Documentation

Education

Bachelor’s/Master’s degree

Tools

SAP

MasterControl

MES

LIMS

QMS

Workflow platforms

Job description

Prothya Biosolutions in Amsterdam seeks an experienced Validation Lead to drive CSV/CSA within GMP environments. You will define and execute risk-based validation strategies for IT/OT systems and projects, ensuring alignment with EU GMP Annex 11 and data integrity.

You will integrate validation into project plans, oversee IQ/OQ/PQ, risk assessments, and traceability, and coach cross-functional teams. Engage with QA, IT, Engineering and Manufacturing to uphold high compliance standards.