Validation Engineer

About the role

Gerresheimer, a global partner for pharmaceutics, biotech, healthcare and cosmetics, is looking for a Validation Engineer. The role covers planning, coordinating and executing qualification, requalification and validation activities within projects, monitoring quality-related activities and preparing documentation in line with standards, guidelines and regulatory requirements.

Key responsibilities

• Independently plan, coordinate and execute qualification, requalification and validation activities, including evaluation of test results, changes and deviations
• Monitor and ensure implementation of quality-related activities linked to qualification and validation processes
• Prepare and maintain documentation in English according to applicable standards, guidelines and regulations; German is an advantage
• Support and coordinate risk management activities and 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, and drive continuous improvement

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 and practical experience in verification and validation processes
• Good command of written and spoken English; German is an advantage

Required skills

• IT applications, including MS Office, MES and quality management systems
• Structured problem-solving methodologies (e.g. KT)
• Project management methodologies and tools
• Strong technical understanding and attention to detail