Validation Engineer
Company Description
Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.
Job Description
- Independently plan, coordinate, and execute qualification and requalification activities, as well as validation activities within projects, including the evaluation of test results, changes, and deviations.
- Monitor and ensure the implementation of quality-related activities associated with qualification and validation processes.
- Prepare and maintain relevant documentation in English, in accordance with applicable standards, guidelines, and regulatory requirements. Preparation and maintenance of relevant documentation in German is considered an advantage.
- Support and coordinate risk management activities within projects and processes, where necessary.
- Assess changes and their potential impact on the qualified and validated status of test methods, processes, systems, and equipment.
- Prepare customer declarations and related documentation, and communication with customer when necessary.
- Create, maintain, and update test and sample sets.
- Provide support during internal, external, and supplier audits.
- Independently develop, revise, and improve relevant operational procedures, work instructions, forms.
- Drive continuous improvement initiatives within the area of responsibility.
- Documentation management and good documentation practice
Qualifications
- Completed technical university degree (minimum three years of academic education).
- At least five years of relevant professional experience in quality assurance, qualification, and/or validation.
- Specialized knowledge and practical experience in verification and validation processes.
- Good command of IT applications, including MS Office, MES, and Quality Management systems.
- Knowledge of structured problem-solving methodologies (e.g. KT).
- Strong technical understanding and the ability to work with technical specifications.
- Familiarity with project management methodologies and tools.
- Structured, systematic, and detail-oriented approach to work.
- Good command of written and spoken English.
- German language skills are considered an advantage
Additional Information
Be part of a team where quality makes a difference!
Join our international environment and contribute to ensuring the highest standards of quality, compliance, and continuous improvement. Your expertise will play an important role in maintaining reliable processes and supporting successful projects.