- Location
- BE - Verviers, Belgium
- Type
- Full-time
- Department
- Engineering
- Source
- Workday
Description
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.
As the Computer System Validation (CSV) Expert you will report directly to the local CSV manager and be the domain expert responsible for implementing Computer System Validations at our site in Verviers.
Key responsibilities:
- Leading full lifecycle validation for all applicable manufacturing, laboratory and computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and CSV procedure
- Writing validation plan tasks such as Functional, Data Integrity and Audit Trail Risk Assessments; Test Protocols, test scripts and Reports (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)); Traceability Matrix and Validation Summary Report
- Performing periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life
- Prepare Computerized Systems Administration Work Instructions and CS Audit Trail Logbook
- Compiling, maintaining and training managers regarding accurate CSV documentation, ensuring full traceability across its lifecycle
- Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety, product quality and data integrity
- Participating in both internal and external audit inspections from a CSV perspective
Key requirements:
- Several years of experience in CSV function within the life sciences industry
- Solution focused mentality with capability of prioritizing tasks and managing multiple projects parallel
- In depth knowledge of GAMP5 and a broad understanding of validation principles in general
- Good knowledge of FDA / MHRA and other governing bodies regulations and requirements for GxP, data integrity and data governance
- A steadfast focus on eliminating waste to increase value for our leadership teams the core of our continuous improvement approach
- Proficient French and English language skills both written and verbal
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.
