QA Method & Process Validation Specialist (m/f/d)

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 as a QA Method & Process Validation Specialist in Geleen, Netherlands, where your expertise will contribute to our world-class standards in life sciences. At Lonza, our ongoing growth provides outstanding opportunities for hard-working individuals to make a significant impact on both the company and the broader community. This role is pivotal to ensuring the flawless execution of our validation processes, improving the quality and reliability of our products.

Key responsibilities:

• Review and approve documentation related to the qualification, validation, and verification of QC analytical methods.
• Quality oversight of validation of manufacturing, cleaning, disinfection, and shipping processes.
• Offer validation knowledge support for projects to guarantee compliant analytical, manufacturing, and shipping processes.
• Ensure that deviations and change records are well detailed, and applicable corrective actions and systemic solutions are applied.
• Comply strictly with Good Manufacturing Practices (GMP) guidelines in all activities.
• Collaborate with teams to successfully implement quality management and GxP regulations.

Key requirements:

• A bachelors degree in biotechnology or a related field.
• Over 5 years of experience in preferably MSAT, QC QA, or PD with a strong lab background in testing.
• Proven expertise in validation and report authoring.
• Excellent problem-solving skills with the ability to communicate effectively and make fast-paced decisions.
• In-depth knowledge of GMP, quality management, European and FDA regulations, cGMP, and GDP.
• Strong knowledge of validation methodologies and manufacturing processes.
• Outstanding analytical skills with a detailed approach to problem-solving.
• Ability to work autonomously with sound industry knowledge and project proficiency.

Become part of a company where your ambition and dedication will be rewarded with the opportunity to compete at the highest level and achieve outstanding results. Successfully implement your skills and make an impact at Lonza AG!

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.