Senior IT Validation Lead, GxP Compliance & CSV

EPM Scientific; Amsterdam; On-site; EUR 70,000 - 110,000; Full time

Job summary

EPM Scientific is seeking an experienced IT Validation Specialist to support GxP validation and compliance activities in a highly regulated life sciences environment. The role focuses on ensuring risk-based validation of IT and automation solutions across enterprise applications, manufacturing systems, and integrations.

You will lead validation strategies, support audits and regulatory inspections, and drive standardisation of validation practices while collaborating with Quality, Manufacturing,

Qualifications

• 8+ years of CSV, CSA or Validation Engineering experience.
• Strong expertise in validation risk assessments and validation lifecycle management.
• Experience validating automated systems within GMP-regulated environments.
• Knowledge of: GAMP 5, CSA principles, FDA 21 CFR Part 11, EU GMP Annex 11, Data Integrity.
• Experience supporting audits and regulatory inspections.
• Excellent stakeholder engagement and communication skills.
• Experience with SAP validation, MasterControl, MES, LIMS and QMS platforms.

Responsibilities

• Develop and execute risk-based validation strategies for GxP-regulated systems.
• Lead validation activities for system implementations, upgrades and integrations.
• Review requirements, system designs, configurations and functional specifications.
• Support validation of IT and automation/OT solutions.
• Ensure validation requirements are incorporated into project delivery plans.
• Author and review validation documentation including IQ/OQ/PQ protocols and traceability matrices.
• Maintain inspection-ready documentation throughout the system lifecycle.
• Support change control, deviations, CAPA activities and investigations.
• Collaborate with Quality, Manufacturing, Engineering and IT teams.

Skills

CSV/CSA expertise

Regulatory compliance

Stakeholder management

Audits & inspections

Project governance

Education

Bachelor's degree in Engineering, IT, Computer Science, Life Sciences

Tools

MasterControl

SAP validation

MES

LIMS

QMS platforms

Job description

EPM Scientific is seeking an experienced IT Validation Specialist to support GxP validation and compliance activities in a highly regulated life sciences environment. The role focuses on ensuring risk-based validation of IT and automation solutions across enterprise applications, manufacturing systems, and integrations.

You will lead validation strategies, support audits and regulatory inspections, and drive standardisation of validation practices while collaborating with Quality, Manufacturing,