Paul (Dr.-Ing.) Van Marcke

• Handled the Validation Plan as the SGIE Val Expert for 2 SCADA Filling lines (Project Dolfin, Project Orca).
• Provided technical support for CSV on Bausch & Ströbel Filling Line 3 including OSI PI for the eLog & eBR.
• Managed validation work scrutinized by SwissMedic and FDA in 2024/2025 with no major findings.
• Conducted training for 120+ lab scientists on Data Integrity (DI) on complex QC laboratory equipment including HPLC, SOLO VPE, HIAC, ICE, Densitometer, and TECAN.
• Managed integration to iLAB and LIMS and direct involvement in re-qualification of QC complex lab instruments.
• Led FDA Audit on Data Integrity in November 2022 (zero findings) and two SwissMedic Audits (zero findings).
• Served as Quality Senior Specialist SGIE (Strategic Growth and Investment Engineering) on a newly acquired filling station.
• Authored validation plans, test protocols (IQ/OQ/PQ), traceability matrices, and requalification documentation.
• Rewrote and amended numerous SOPs and full CSV/Data Integrity reporting and testing.

• Reworked URS and Project Plan for a new Central Laboratory Information Center for Sanquin Reagentia and Sanquin IVD.
• Performed URS, Project Plan, and document checks as per new IVD rules.

• Performed process assessments for QC Insulin, including PFD and DFD (Process and Data Flow Diagrams) linked to Glass Walls.
• Applied ALCOA and Risk-ranking principles, including full flowchart interactions in swim lanes with Visio grouping results from production, order management, and QC.

• Managed the integration of Glassia OSI PI plant software.
• Authored and obtained approval for URS, RATM, and FMEA as per ISO 13485 and ISO 14971.
• Developed DS, HDS, and FS to start work on IOPQ with HPALM.
• Prepared engineering runs and completed over 80 remote CSV and safety trainings.
• Acted as a sparring partner for mapping issues between old and newly formulated procedures and Item Numbers.

• Test Method Validation (TMV) Engineer for mechanical gages and electronic devices.
• Computer Systems Validation (CSV) Engineer as per FDA rules for three core systems related to the production of printed board components (SMDs).
• Authored over 150 pages of CSV text per system.

• Project Lead for Serialization of blister production and packaging.
• Full-scale preparation for FDA CSV Audit and Arzneiheilmittelinspektorat Basel.
• Successfully handled audits in 12/2017 by FDA and Regionales Heilmittelinspektorat with zero findings.
• Lead QA for Novartis Audit on Data Integrity in 03/2018.

• Defined requirements for the Manufacturing Execution System (Siemens Simatic eBR electronic Batch Record-suite).

• Led the GRQP-Project in Umkirch including Test Methods Validation for gages and measuring equipment.
• Prepared sites in Umkirch, Tuttlingen, and Salzburg for JJRC Regulatory Compliance audits.
• Designed and executed IQ/OQ/PQ tests for machines, clean rooms, lab metrology devices, lab bioburden sampling testing units, and endotoxin devices.
• Rewrote multiple SOPs on validation and reworked CSV-SOPs.

Subject: Senior Computer Systems Validation & SCADA Systems / PhysChem & Bioassay Test Methods Validations /Data Integrity Dear Sir or Madam, My name is Paul van Marcke. Since 2015, I have been working as an independent CSV engineer, supporting international clients in regulated pharmaceutical and MedTech environments. I bring a combined background in the automotive and electromechanical industries, including roles at Hayek/Swatch Group (Switzerland), Blumhardt Fahrzeugwerke (Germany), Lexus (Brussels), and Hilti AG (Liechtenstein), along with approximately ten years as a sworn translator and interpreter for the European Commission. I have successfully delivered projects for companies such as Novartis, Johnson & Johnson, Merck, Lonza, Takeda, BioNtech and GSK and I communicate fluently in German, English, French and Dutch. My expertise covers the development, implementation, and validation of test methods and test setups, including verification and system testing in GxP-regulated environments. I have extensive hands-on experience in biochemical and electromechanical laboratory and manufacturing settings (R&D, metrology, production), including machining and non-machining processes, notably at LivaNova in Munich. Core expertise (summary): ISO 13485 – Quality management systems for medical devices and related services ISO 62304 – Lifecycle requirements for medical software development and maintenance ISO 14971 – Risk management for medical devices across the entire lifecycle FDA QSR – FDA quality system requirements for medical devices 21 CFR Part 11 – Requirements for electronic records and electronic signatures 21 CFR Part 820 – FDA regulatory framework for medical device quality systems FDA 483 – FDA observations and warning letter support I support the preparation and review of SOPs, CAPAs, change requests, and technical documentation, as well as design changes, product optimizations, and market feedback analysis. I also provide hands-on preparation and support for FDA, SwissMedic, TÜV, ANVISA, and mock audits, delivering fully traceable and compliant documentation. I am currently available for new assignments in CSV, QA/Validation, Verification Testing, Design Assurance, and related disciplines, offering rapid availability, flexibility, and senior-level delivery. I would welcome the opportunity to discuss how I can support your organization. My full CV is available on request. Kind regards,

Paul van Marcke-Iskenderian Dr. (PhD), Dipl. Ing (Uni), Dipl. Ing (FHS), MBA Mobile: 00352 661 707 515 Email: [email] My Profile: linkedin.com/in/paul-van-marcke-b8a28723

• Analyzed business processes and logistics.

• Developed work methods and generated HTML data flows for customer satisfaction.

• Provided linguistic services for the Directorate-General for Enlargement.

• Re-visited and re-trained all DIN EN ISO 9001:2000 and ISO 14001:2004 processes.
• Performed watchdog function for all European Commission translation work.

• Conducted customer relations analyses.

• Specialized in contractor work including Process Management, Engineering, Linguistic Engineering, and IT.

• Addressed performance issues for Swatch Group, Brökelmann Aluminium Presswerk, and various public service departments.

• Managed central steering of work orders with 11 subordinate colleagues.
• Conducted time studies using REFA methodology on 8 assembly lines with a head count of 13 across 13,000 positions.