QA (senior) CQV Specialist

QA (Senior) CQV Specialist

Location: 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.

Are you an experienced professional with a keen eye for quality and documentation? We are looking for QA ( Senior ) CQV Specialis t who plays a crucial role in ensuring the highest standards within our organization. It is important to note that this role is not focused on operational execution. We are seeking QA candidates who are not involved in technical execution.

At Lonza, the engineers execute the qualification tests, while the QA professional is responsible for reviewing and approving protocols and tests. The QA person does not execute the qualifications. Instead, you will focus on reviewing and approving protocols and documentation related to the qualification and validation of equipment, facilities, and utilities. You will ensure that all validation documents and procedures, including those for operations, cleaning, and maintenance, are appropriately documented. When deviations occur, you will be involved in ensuring that all necessary corrective actions and systemic solutions are properly implemented.

What you will do:

• Review and approve: User Requirement Specifications (URS), qualification and validation plans, validation documentation (DQ, IQ, OQ, PQ) and risk assessments related to for equipment, facilities, and utilities

• Coordinate commissioning protocols and reports

• Review and approve FAT/SAT documentation and Validation Life Cycle Documentation

• Ensure accurate application of validation quality systems and develop improvement plans

• Conduct periodic reviews of validated GxP equipment, facilities, and utilities

• Quality oversight on validation impact assessments prior to changes on equipment, facilities, or utilities

• Provide support for quality-related issues, including GMP regulations and internal SOP compliance

• Assist production and technical service teams with validation activities

• Manage validation deviations and CAPA processes

• Contribute to continuous improvement and international standardization

What you will bring:

• Bachelor's degree in a scientific or technical field (minimum)

• Minimum 1 -3 year of experience in validation activities within a pharmaceutical or biotech manufacturing environment

• Quality assurance experience with a focus on technical installations (facility/utility)

• Expertise in HVAC, autoclave, VHP, purified water, and process gases

• Experience with laboratory systems in a pharma environment

• Understanding of regulatory requirements and industry standards (FDA, EMA, ICH, etc.)

• No company visa sponsorship available for this role

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.