Vacature QA Validation Specialist

QA Validation Specialist in Geleen

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Join Lonza AG in Geleen, Netherlands as a QA Validation Specialist, ensuring top-notch equipment, facilities, and utilities to support our life sciences solutions. Your role is vital to upholding our quality standards and driving ambitious growth.

• Coordinate validation and qualification deliverables to ensure they are completed impeccably.
• Evaluate and endorse URSs, qualification, and validation plans, along with all documentation related to equipment, facilities, and utilities (DQ, IQ, OQ, PQ).
• Conduct risk assessments and review commissioning protocols and reports.
• Assure requirements traceability throughout the entire project validation file.
• Manage the validation life cycle documentation and ensure the accurate application of validation quality systems.
• Conduct regular assessments of verified GxP machinery, buildings, and services.
• Conduct validation impact assessments prior to implementing changes.
• Provide support in quality-related issues, ensuring compliance with GMP regulations and internal SOPs.
• Support production and technical services teams with validation activities.
• Manage validation deviations and potential CAPAs, ensuring detailed documentation and corrective action follow-up.
• Contribute to continuous improvement and international standardization for equipment, utilities, and facilities.
• Fully align with Good Manufacturing Practices guidelines in all activities.

• Proven experience with Quality Management and GxP regulations.
• In-depth knowledge of validation methodologies and quality systems, including European and FDA regulations, cGMP, and GDP.
• Detailed understanding of manufacturing processes.
• Outstanding analytical skills with a detailed approach to problem-solving.
• Ability to break down complex issues into manageable tasks for personnel.
• Solid industry understanding, project expertise, and the independence to complete tasks successfully.
• Excellent communication and collaboration skills.

Come aboard Lonza AG, where your input will enable us to excel at the highest standards and create a meaningful difference in countless lives daily!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.