IT Validation Specialist (12 months)

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

We are seeking an experienced IT Validation Specialist to support validation and compliance activities for GxP-regulated systems within a highly regulated life sciences environment. The position will play a critical role in ensuring that IT and automation solutions are implemented using risk-based validation methodologies while maintaining compliance with global regulatory requirements.

This is a key position supporting digital transformation initiatives, enterprise applications, manufacturing systems, infrastructure projects, and system integrations across the organisation.

Key Responsibilities

• Develop and execute risk-based validation strategies for GxP-regulated systems
• Ensure compliance with CSV, CSA, Data Integrity, FDA 21 CFR Part 11 and EU GMP Annex 11 requirements
• Provide expert validation guidance during audits, inspections and quality assessments
• Drive standardisation and continuous improvement of validation practices

System & Automation Validation

• Lead validation activities for system implementations, upgrades and integrations
• Perform impact assessments and validation risk assessments
• Review requirements, system designs, configurations and functional specifications
• Support validation of both IT and automation/OT solutions
• Ensure validation requirements are incorporated into project delivery plans

Documentation & Lifecycle Management

• Author and review validation documentation including:
• Validation Plans
• IQ/OQ/PQ Protocols
• Traceability Matrices
• Validation Summary Reports
• Maintain inspection-ready documentation throughout the system lifecycle

Quality & Governance

• Support change control, deviations, CAPA activities and investigations
• Ensure validation activities align with quality and regulatory expectations
• Promote risk-based decision making within project teams

Stakeholder Management

• Collaborate with Quality, Manufacturing, Engineering and IT teams
• Provide mentoring and guidance on CSV/CSA best practices
• Coordinate validation activities with external vendors and implementation partners

Required Experience

• Bachelor's degree in Engineering, IT, Computer Science, Life Sciences or a related discipline
• 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 requirements
• Experience supporting audits and regulatory inspections
• Excellent stakeholder engagement and communication skills
• SAP validation
• MasterControl
• MES
• LIMS
• QMS platforms
• OT validation
• Digital transformation projects

Ideal Candidate Profile

An experienced CSV/CSA professional with a strong background in regulated pharmaceutical or biotech environments. The ideal candidate has extensive experience conducting validation risk assessments, leading automation and system validation activities, and developing compliant validation strategies across complex IT and manufacturing environments. They will be comfortable working independently while influencing quality, engineering, manufacturing and IT stakeholders.