Project Experience
Over 16 years of experience delivering critical validation services for pharmaceutical and healthcare industries, partnering with industry leaders on complex automation projects.
Johnson & Johnson Innovative Medicine
Client: Janssen Pharmaceuticals API Manufacturing Plant
Sr CSV Engineer
Geel, Belgium
Working as Senior CSV Engineer at Janssen Pharmaceuticals API manufacturing plant, responsible for commissioning qualification and validation of automation systems.
Key Responsibilities
- Commissioning Qualification and validation of Delta V systems
- Commissioning Qualification and validation of PCS7 systems
- Implementation of change controls for equipment integration
- Validation and qualification of new equipment integration into plant DCS system
Lonza Netherlands B.V
Senior CSV Engineer & Automation Engineer
Netherlands
Worked as senior validation engineer, qualifying Automation systems and Equipment for a newly constructed facility for clinical manufacturing of mRNA vaccines.
Key Responsibilities
- Qualification of automation systems for mRNA vaccine manufacturing
- Close collaboration with vendors for commissioning and qualification
- IT qualification of QC laboratory systems (DLS, Micro Plate readers, HPLCs)
- Authoring validation deliverables: System validation plans, Design Qualification, Test protocols
MSD Animal Health
Site CSV - IT Automation Engineer
De Bilt, Netherlands
Worked on the Innovax project, qualifying Automation systems and Equipment for a newly constructed facility for manufacturing vaccines for chickens.
Key Responsibilities
- IT qualification and commissioning activities on Fedegari equipment
- Filling line systems qualification (Tunnel, Filling machine, Labelling)
- Authoring QAP, vulnerability scan reports, Design Qualification
- Test protocols (FAT, SAT, UAT, IOQ) development and execution
Thermo Fisher Scientific
Site CSV Engineer
Tilburg, Netherlands
Responsible for validating and qualifying new computerized systems and equipment at the pharmaceutical manufacturing facility.
Key Responsibilities
- Validating/qualifying new computerized systems and equipment
- Maintaining GxP computerized systems in validated state
- Implementing change controls with proper quality
- Periodic reviews: annual user reviews, system reviews, data integrity assessment
Atos Global IT Solutions
Client: MSD Animal Health, Boxmeer
Site CSV - IT Automation Lead
Boxmeer, Netherlands
Led the SFFD project, qualifying Automation systems and Equipment for a newly constructed Sterile Filling and Freeze-Drying vaccines facility.
Key Responsibilities
- Led IT Automation qualification for SFFD project
- Single point of contact for Optima filling lines automation
- Successfully validated SCADA system end-to-end including Simatic Batch
- Qualification Lead for Optima Filling machines and Freeze Dryers
Wipro Technologies
CSV QA IT
Various Locations
Worked as CSV-QA for major pharmaceutical clients including Johnson & Johnson (Lifescan) UK and Noramco USA, reviewing and approving validation deliverables.
Key Responsibilities
- Reviewed and approved project Validation Deliverables
- Authored Validation Plan and Validation Summary Reports
- Guided project teams on validation activities per local CSV procedures
- Reviewed UAT scripts for ORACLE JDE Edwards Data Migration
Notable Accomplishments
mRNA Vaccine Facility Qualification
Led automation qualification for cutting-edge mRNA vaccine manufacturing facility at Lonza Netherlands.
End-to-End SCADA Validation
Successfully validated complete SCADA system including Simatic Batch and Line Batch Management at MSD.
Optima Filling Line Lead
Served as single point of contact for Optima filling lines automation qualification including freeze dryers.
Let's build together
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