Validation Engineer

About the role

Gerresheimer is looking for a Validation Engineer in its Technological Industrial Development Zone in Skopje, North Macedonia. The role covers planning, coordinating and executing qualification, requalification and validation activities, monitoring quality-related activities, preparing documentation and supporting audits.

Key responsibilities

• Independently plan, coordinate and execute qualification, requalification and validation activities, evaluating test results, changes and deviations
• Monitor and ensure quality-related activities linked to qualification and validation processes
• Prepare and maintain documentation in English according to standards, guidelines and regulations; German is an advantage
• Support and coordinate risk management, assess changes and their impact on qualified and validated status
• Prepare customer declarations and communicate with customers when needed
• Create, maintain and update test and sample sets
• Support internal, external and supplier audits
• Develop, revise and improve operational procedures, work instructions and forms
• Drive continuous improvement and manage documentation

Required profile

• Technical university degree (at least three years of study)
• At least five years of experience in quality assurance, qualification and/or validation
• Specialized knowledge of verification and validation processes
• Good command of written and spoken English; German is an advantage
• Structured, systematic and detail-oriented approach

Required skills

• MS Office, MES and quality management systems
• Knowledge of structured problem-solving methods (e.g. KT)
• Project management knowledge and familiarity with technical specifications

What we offer

• On-site canteen with food and drinks
• Regular training and coaching
• Company pension
• Organized transport facilities and transportation allowances