Supporting (BIO) Pharmaceutical and Medical Device Companies

Providing operational support for MES software in a GMP (Good Manufacturing Practices) regulated environment, including:

Software deployment
Incident management
Problem management
Lifecycle management
System maintenance
Training
Validation (GAMP5, Computerized Systems Validation)

Responsibilities also include managing application upgrades, projects, enhancements, and security patches.

I bring comprehensive IT and automation integration expertise, combined with strong communication skills in Dutch and fluent English (both verbal and written). This enables me to effectively liaise with customers, vendors, and IT and engineering experts (e.g., application, network, database specialists) locally and across multiple sites. I excel at translating technical concepts into user-friendly language, bridging the gap between business and IT.

I am accustomed to adhering to GMP/GCP procedures and ensuring that new systems are implemented in compliance with FDA/EMA and other regulatory requirements. My experience includes working in global, cross-functional, and virtual teams across different time zones.

Proficient in developing and executing SOPs, as well as Installation and Operational Qualification (IQ/OQ) protocols, I have a solid understanding of FDA GxP and 21 CFR regulations. I am also well-versed in software system validation and working with solution lifecycle methodologies, such as Agile.

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets. By combining technological insight with world-class manufacturing, scientific expertise and process excellence, we help our customers to deliver new and innovative medicines that help treat a wide range of diseases. 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 commitment and ideas that help our customers 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. Our work makes A Meaningful Difference.