Oss, North Brabant, Netherlands
Operational Technology and informatics an Experienced CSV Specialist and with over 20 years in the pharmaceutical and biotech industries. Currently working at Synaffix (part of Lonza) as an Operations Technology & Informatics Engineer, where I manage GxP laboratory systems, system lifecycles, validation activities, and serve as system administrator for lab-critical software. I act as a key link between lab operations, IT, engineering, and global compliance, ensuring seamless performance of computerized systems in a regulated GMP environment. Previously held leadership roles including Lead CoE CSV at Agidens and Asset Manager Computerized Systems at MSD Biotech, where I oversaw validation of systems aligned with GAMP 5, 21 CFR Part 11, and ALCOA+ principles. As Principal Consultant at QBD, I advised clients on CSV/CSA strategy, data integrity, and compliance. Skilled in: - GMP lab system administration and OT infrastructure - Computerized system validation (IQ/OQ/PQ) - Risk assessments and regulatory audits - Change control and lifecycle management - Business consulting and stakeholder engagement Certified Lean/Six Sigma Green Belt with a strong track record in quality systems, coaching teams, and leading validation and compliance projects. Passionate about delivering reliable, compliant, and future-proof technology solutions that enable scientific innovation.
Managing the lifecycle and administration of laboratory computer systems critical to the development of antibody-drug conjugates (ADCs). In this standalone role, I ensure seamless operation of lab software and infrastructure, supporting system validation, ensuring data integrity, and maintaining compliance with regulatory standards such as GAMP and 21 CFR Part 11. As system administrator, I troubleshoot issues, coordinate with vendors, and collaborate closely with lab operations, IT, engineering, and manufacturing to keep systems secure, reliable, and fit for purpose. Key Responsibilities: - Manage the full lifecycle of lab systems—from installation and configuration to maintenance and decommissioning. - Act as system administrator for laboratory software, ensuring proper access control, performance, and data management. - Provide validation support, including preparation of IQ/OQ documentation and configuration of systems within the OT landscape. - Troubleshoot and resolve technical issues, lead change control efforts, and implement corrective actions where needed. - Ensure internal procedures and systems align with external regulations (e.g., GAMP, 21 CFR Part 11) and evolving best practices. - Advise project teams and lab users on system capabilities, performance improvements, and compliance requirements. - Support integration of lab applications into the Lonza operational technology (OT) environment.
Video Filming and Editing Studio Corporate films made under name Hak en Haai productions and 4iFocus. Videographer since 1985. Filming with a Sony HDR-HC5E. with ND filters and Raynox lenses. 3 close-up lenses (+1, +2 and +4) For my semi-professional projects I use a Sony DSR-PD150 DVCAM. Editing in Adobe Premiere (since 2006) and Pinnacle studio Trainer in Pinnacle Studio. Several projects for Industries and clubs www.vimeo.com/hakenhaai
Managing various projects within highly innovative environments in the life science industry, with focus on validation and qualification. This can range from one large scale project to combining 3 to 4 different smaller projects at the same time. Ensuring the successful planning, execution, and completion of validation and qualification projects within the life science sector. Draft, implement and actively manage project plans and have a continuous overview over the timeline, budget and resources. Negotiate and communicate with C-level (management) and chair steering committees to report about the project status to the different stakeholders. Independently escalate problems to the client in a timely manner and work with them to find solutions. Oversee the development and maintenance of comprehensive validation documentation, including protocols, reports, and standard operating procedures (SOPs), in line with quality and regulatory requirements. Provide guidance and support to ensure the team’s alignment with project goals and company objectives. Identify potential risks and challenges associated with validation projects and develop mitigation strategies. Collaborate with our sales team and Division Head, and support them technically in making proposals to clients.
Consultant CSV DI life sciences Working @ MSD
Responsible for the optimization, performance and reliability of technical systems, analytical lab equipment and automated process installation. -Purchase and implementation of new technical systems -Coordinator of implementation projects within the USP production department. -Part of site-wide investment projects. -Establish principles for new technical systems ensuring process, GMP, safety, and user requirements and compliance. -Implementation with an executive role during commissioning, qualification and retirement, following the Computerized System Validation (CSV) principles. -Improve/optimize technical systems under your management as a system owner -Determine need for system optimizations, and develop a business case. -Manage portfolio of ongoing improvement initiatives data integrity and implement actions in the department -Automated process installations and lab equipment. Focus on maintaining the operational functioning/reliability and the qualified GMP status of these systems. System management: -POC technical malfunctions and action holder in search for a solution. -Define necessary tasks to maintenance and data integrity during the life cycle of technical systems and monitor their implementation. - Handle system-related technical deviations, apply root-cause analyzes and problem-solving techniques. -Receive / guide external parties in maintenance activities. -Represent the M&R department as system owner during audits / inspections. -Periodic review systems under your management and decide whether this system is operationally reliable and inspection-ready. -Assessing maintenance performed, system deviations that have occurred, and compliance of the system and associated system documentation with respect to the applicable QMS. -Expert CSV and data integrity (DI). -Central to improvement processes and new technical system implementations -Ensure connections between M&R and other departments, within and outside the USP production department.