Validation Engineer

Sire Search; Breda; On-site; EUR 60,000 - 90,000; Full time

Job summary

The Validation Engineer will join a global pharmaceutical manufacturing organization to support commissioning, qualification and validation activities for secondary packaging systems and computerized systems.

In this GMP regulated environment you will develop documentation, execute testing, and ensure inspection-ready records while coordinating with cross-functional teams to meet quality and regulatory expectations.

Qualifications

• Minimum 3 years of commissioning, qualification, and validation experience in pharmaceutical manufacturing.
• Experience with secondary packaging systems.
• Experience with print and inspection systems (Systech, Cognex).
• Knowledge of computerized systems validation.
• Hands-on commissioning/qualification in secondary packaging operations.
• Strong validation lifecycle documentation knowledge.
• GMP-regulated environment experience.
• Excellent technical writing skills in English.
• Strong communication and stakeholder management.
• Independent work with limited supervision.
• Strong project coordination and prioritization.

Responsibilities

• Develop and maintain validation documentation including criticality assessments, qualification plans, validation plans, risk assessments, test protocols, traceability matrices, and summary reports
• Lead commissioning, qualification, and validation activities for manufacturing systems
• Execute testing activities and document results according to GMP requirements
• Support project teams to ensure technical solutions comply with validation plans and internal procedures
• Provide technical guidance throughout project execution
• Ensure documentation is complete, accurate, and inspection ready
• Support project delivery through design, implementation, testing, commissioning, and validation phases
• Complete additional assignments and projects as requested by management

Skills

Independent work

Attention to detail

Problem solving

Project coordination

Strong communication

Technical writing

Stakeholder management

Tools

Systech

Cognex

Job description

The Company

A global pharmaceutical manufacturing organization focused on delivering high quality healthcare products through advanced production technologies and strict regulatory compliance. The company operates in a highly regulated environment and emphasizes innovation, quality, operational excellence, and patient safety.

Role description

The Validation Engineer supports engineering and validation projects within a GMP regulated manufacturing environment. This role focuses on commissioning, qualification, and validation activities for secondary packaging systems and computerized systems. The position requires strong technical expertise, documentation skills, and the ability to work independently while ensuring compliance with established quality standards and procedures.

Responsibilities

• Develop and maintain validation documentation including criticality assessments, qualification plans, validation plans, risk assessments, test protocols, traceability matrices, and summary reports
• Lead commissioning, qualification, and validation activities for manufacturing systems
• Execute testing activities and document results according to GMP requirements
• Support project teams to ensure technical solutions comply with validation plans and internal procedures
• Provide technical guidance throughout project execution
• Ensure documentation is complete, accurate, and inspection ready
• Support project delivery through design, implementation, testing, commissioning, and validation phases
• Complete additional assignments and projects as requested by management

Requirements

• Minimum 3 years of commissioning, qualification, and validation experience within pharmaceutical manufacturing
• Experience with secondary packaging systems
• Experience with print and inspection systems such as Systech and Cognex
• Knowledge of computerized systems validation
• Hands on commissioning and qualification experience within secondary packaging operations
• Strong understanding of validation lifecycle documentation
• Experience working in a GMP regulated environment
• Excellent technical writing skills in English
• Strong communication and stakeholder management abilities
• Critical thinking and problem solving skills
• Ability to work independently with limited supervision
• Strong project coordination and prioritization capability