Validation Quality Engineer
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
For our capsule manufacturing site in Belgium, Bornem we are looking for a Validation Quality Engineer. In this role, you will be responsible for the coordination of the overall site validation plan and have the opportunity to set out the framework that drives consistent validation in line with regulatory and GMP requirements. You will report to the Site Quality Head.
Maintain the site validation master plan, issue review reports and decide on requalification needs for existing processes.
Create and maintain the validation SOPs, including validation templates, conform corporate policy, regulatory requirements and GMP standards.
Set out the framework and planning to ensure consistent follow up of validation test execution by the engineering and technician Subject Matter Experts (SMEs)
Represent the quality department in project teams aimed at continuous improvement and ensure quality compliance requirements are taken into account in defining user specifications.
Validation Subject Matter Expert
Within the change control process, assess validation need and draft appropriate validation documentation.
Review and approve technical qualification reports based on user requirement specifications (equipment, process, software, supplier, QC test methods, e.a.).
Provide guidance towards the validation executers in defining appropriate test methods.
Function as QA lead or as test executer reprenting the quality department where needed.
Drive the projects related to quality systems software improvements, in coordination with the development team and quality engineers.
Provide coaching and training on all aspects of validation and qualification and primary point of contact towards other Lonza sites with regards to questions related to local validation files.
Take part in customer and 3rd party audits further to the validation process and define appropriate CAPAs in response to observations.
Superuser for the software systems, providing day to day support to the quality engineers related to quality investigations.
Report and follow trough on validation KPIs.
Organize regular follow up meetings with involved stakeholders and determine appropriate actions in case of adverse trends.
Take part in quality review sessions and formulate proposals for improvement of the validation processes.
Master degree in engineering, pharmacy, biotechnology or equivalent.
At least 3 years of relevant validation experience in a pharma, biotech or life sciences environment.
In-depth knowledge of GMP and an understanding of pharmaceutical regulatory requirements.
Hands-on, pragmatic and a positive problem-solving mindset, able to work in a complex environment with different stakeholders and with continuously evolving developments.
Profound experience in one or more of the following domains is considered an asset:
Computer System Validation and understanding of FDA Title 21 CFR Part 11 guidelines
Automation development IQ/OQ/PQ testing
Compliance experience in laboratory and analytical method validation, knowledge of Pharmacopeia test methods
Supplier and product qualification and testing
Fluent written and oral communication in Dutch and English, French is an advantage.
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.