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Paul (Dr.-ing.) V.

CSV Lead

Wuermeldeng, Luxembourg

Experience

Jan 2022 - May 2023
1 year 5 months
Jena, Germany

CSV Lead

CZ Carl Zeiss Vision

  • CSV Lead on a very large SCADA / Polarion / Siemens integration project involving 10+ interacting companies.
  • CSV integration for Siemens Polarion / Avasis / Azure.
Jul 2021 - Oct 2024
3 years 4 months
Basel, Switzerland

CSV Filling Line 3 / SCADA Specialist (Project Dolfin & Project ORCA) / QA & Data Integrity Expert / Quality Senior Specialist

Lonza

  • Led the Validation Plan as SGIE Validation Expert for two SCADA filling lines (Project Dolfin and Project ORCA).
  • Handled QA and wrote the Validation Plan plus CSV documentation for three manufacturing projects: Bausch & Ströbel Filling Line 3 tech support CSV, OSI PI/SCADA Dolfin Line (MODA-ES by Lonza) eLog & eBR, and SCADA ORCA Line eLog & eBR at the manufacturing site.
  • Managed full CSV and data integrity reporting and testing, and later served as QA Validation expert on complex lab equipment like HPLC, SOLO VPE, HIAC, ICE, densitometer, Tecan, including integration with iLAB and LIMS.
  • Trained over 120 lab scientists on data integrity in complex QC laboratory equipment.
  • Took part in re-qualification of complex QC lab instruments and rewrote and updated numerous SOPs.
  • My work was reviewed by SwissMedic and the FDA with zero major findings. FDA audit on data integrity in November 2022 (zero findings), and two SwissMedic audits (zero findings).
Jun 2021 - Sep 2021
4 months
Lonay, Switzerland

CSV Expert

Merz

  • CSV Expert for complex QC machines including refrigerator, oven, UHPLC, rheometer, test bench, and gas chromatograph.
Jan 2021 - Jun 2021
6 months
Neuenburg am Rhein, Germany

Consultant

Nemera

  • Adapted technical specifications for an injection product to meet US and EU non-civil standards, according to 21 CFR 820.
Dec 2020 - Feb 2021
3 months
Amsterdam, Netherlands

Ad Hoc / Short Term Consultant

Sanquin bv

  • Revised the URS and project plan for a new central laboratory information center for Sanquin Reagentia and Sanquin IVD.
Feb 2020 - May 2020
4 months
Frankfurt am Main, Germany

Data Integrity Expert ALCOA

Sanofi

  • Short-term Data Integrity Expert for QC Insulin, specifically for process assessments, PFD and DFD (process and data flow diagrams) linked to glass walls.
  • Worked following ALCOA and risk-ranking principles, including full flowchart interactions in swim lanes using Visio, grouping all results and data from questionnaires in production, order management, and QC.
Oct 2019 - Jan 2020
4 months
Neuenburg am Rhein, Germany

Consultant / Trainer

Nemera

  • Trained the entire QC staff on all 125 GMP critical SOPs (Manufacturing Instructions and Testing Instructions) through 77 group training sessions.
  • Systematically updated SOPs where needed.
Sep 2019 - Sep 2020
1 year 1 month
Lessines, Belgium

Sr. Computerized Systems Validation Expert

Takeda Shire Baxter

  • CSV expert for the OSI PI and SCADA systems for eLog and eBR at the Glassia plant.
  • Acted as a sparring partner for mapping issues from old to newly defined procedures and item numbers.
  • Co-wrote and obtained full approval for URS, RATM, FMEA (per ISO 13485 ref. ISO 14971), DS+HDS+FS to start work on IOPQ with HPALM.
  • Prepared engineering runs.
  • Completed all CSV and safety training remotely (80+ sessions).
Jun 2019 - Oct 2019
5 months
Aalen, Germany

Study Lead UDI strategy / Consultant

Carl Zeiss Vision

  • Consulted on UDI (Unique Device Identification) for lenses and optical devices.
  • Authored a position paper on UDI introduction for prescription glasses.
May 2018 - Apr 2019
1 year
Munich, Germany

TMV Engineer / Computer Systems Validation Engineer

LivaNova

  • Test Method Validation (TMV) for mechanical gauges and electronic devices.
  • Computerized Systems Validation (CSV) per FDA rules for three core systems related to the production of printed circuit board components (SMDs).
  • Authored over 150 pages of text for each CSV.
  • Provided timely references and consultations between June and July 2019.
Mar 2018 - Dec 2018
10 months
Wevelgem, Belgium

CSV Manager / CSV Lead

Janssen Vaccines & Prevention bv NL (Johnson & Johnson) / Medgenix

  • CSV Manager for ongoing operations, handling CSV for Waters/Empower HPLC and Shimadzu.
  • CSV Lead for all QC Excel sheets.
Sep 2017 - Jul 2018
11 months
Zofingen, Switzerland

CSV & Data Integrity Manager/Consultant / Project Lead

Arena Pharmaceutical / Siegfried Pharmaceutical

  • Project Lead for the serialization of blister production & packaging.
  • Full-scale preparation for FDA CSV audit & Basel Medicines Inspectorate.
  • Audits in 12/2017 by FDA Regional Medicines Inspectorate resulted in zero findings.
  • In 03/2018, served as Lead QA for a Novartis audit on data integrity.
Aug 2017 - Jan 2018
6 months
Darmstadt, Germany

Sr. Computerized Systems Validation Expert Pharma

Merck KGaA

  • Performed full CSV for Project Eldorado Successor, a completely new design of the Document Management System.
Nov 2016 - Apr 2017
6 months
Germany

URS Requirements Engineer

BioNTech AG

  • Defined requirements for the Manufacturing Execution System (Siemens Simatic eBR electronic batch record suite).
Apr 2016 - Dec 2016
9 months
Wavre, Belgium

CSV Lead

GlaxoSmithKline (Vaccines)

  • CSV Lead for the LIMS IT project, ensuring proper data integration and equipment acceptance validation.
  • Managed the transfer of 55 TB of databases from Novartis Vaccines to GSK Vaccines, including Agilent eLabNoteBooks/reports, schedulers, and Labware.
  • Authored the full documentation for the LIMS IT Data Migration Project.
Apr 2014 - Apr 2016
2 years 1 month
Umkirch, Germany

CSV / TMV / Qualification IT Project Lead

Johnson & Johnson (Synthes Surgery Mechanics)

  • Led the CSV / TMV / Qualification IT project in Umkirch (GRQP-Project).
  • Conducted Test Methods Validation for gages and measuring equipment.
  • Prepared sites Umkirch, Tuttlingen, and Salzburg for the 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.
  • Re-wrote multiple SOPs on validation and completed a full re-work of the CSV-SOPs.
Apr 2013 - Dec 2013
9 months
Basel, Switzerland

MES CSV & Requirements Engineer

Novartis IT ChemOps

  • CSV expert for MES (Manufacturing Execution Systems), including historian, at sites Sankt Johann, Stein, and Schweizerhalle.
Jan 2011 - Present
14 years 11 months
Malibu, United States

Translator

JAKKS Pacific

  • Regularly translate toy portfolios in all EU languages.
Jan 2011 - Dec 2012
2 years
Künzelsau, Germany

BMP Business & Logistics Analyst

A. Würth GmbH & Co KG

Jan 2008 - Dec 2010
3 years
Brussels, Belgium

Free-lance contractor

European Commission, Help Desk, Direction Générale IT

Jan 2008 - Dec 2009
2 years
Brussels, Belgium

Work methods and HTML dataflow generation

Lexus

  • Work methods and HTML dataflow generation for Customer Satisfaction.
Jan 2008 - Dec 2008
1 year
Brussels, Belgium

Strategic Analyst

Hautes Etudes Francisco Ferrer / Institut Cooremans

  • Strategic Analysis of the sustainability of the language courses of the Institute.
Jan 2007 - Dec 2013
7 years
Brussels, Belgium

Free-lance interpreter / translater

European Commission, Directorate-General for Enlargement

Jan 2007 - Dec 2007
1 year
Brussels, Belgium

Consultant

Worldbank

  • As the Presidency of the European Council switched to Germany, the bank requested intensive German language support.
  • Performed multiple consultancy and linguistic tasks.
Jan 2005 - Dec 2010
6 years
Brussels, Belgium

Free-lance contractor

Serco Ltd, / SA

  • Re-visiting and re-training of all the DIN EN ISO 9001:2000 and ISO 14001:2004 processes.
  • Watchdog function for all EC translation work.
Jan 2005 - Dec 2006
2 years
Corbas, France

Translator

Mastic OLIN SA

  • Translation of the full product catalogue in 4 languages.
Jan 2004 - Dec 2005
2 years
Ghent, Belgium

Customer relations analyst

Insurance Brokerage Group Willemot

  • Customer relations analysis.
Jan 2004 - Dec 2005
2 years
Fridolfing, Germany

Developer / Translator

Otto Chemie

  • Developed the SQL algorithms and a linguistic database for 10+ languages for all Product Data Sheets.
  • Translated approximately 120 TechDoc positions in 5 languages.
Jan 1993 - Dec 2003
11 years
Liechtenstein

Product Manager / Global project leader Corporate Business Excellence

Hilti Befestigungstechnik

  • As Product Manager, responsible for approximately 700 products in nearly 27 countries.
  • As Global project leader for Corporate Business Excellence / KPI Customer Perfect Order, managed projects in 25 countries.
  • Developed a new cycle of learning and training for 100+ auditors in ISO 9000/14001.
Feb 1988 - Oct 1989
1 year 9 months
Zürich, Switzerland

Consultant

Hayek Engineering Zürich

  • Addressed performance issues for multiple clients, including:
  • Swatch Group Zürich/Biel
  • Brökelmann Aluminium Presswerk, Wüsten-Neheim
  • Cantonal Tax Service: Tax Office, Bridges and Roads Office / Road and Civil Engineering Office
Oct 1986 - Jan 1988
1 year 4 months
Geneva, Switzerland

Management Trainee, Market Development Engineer Engine Marketing Department

Caterpillar Overseas Geneva – Caterpillar Inc.

Oct 1981 - Dec 1984
3 years 3 months
Algeria

Project Manager

Blumhardt Fahrzeugwerke BRD – Sonacome / SNVI

  • Project 1: Central steering of work orders with 11 subordinate colleagues.
  • Project 2: Conducted time studies (REFA methodology) on 8 assembly lines, with a subordinate head count of 13, covering approximately 13,000 positions (ca. 50,000 work orders).

Summary

Please find my profile below. I would like to express my interest. Here are some notes on my career.

Status: From 2023 to 2025, I led the Validation Plan as SGIE Validation Expert for two SCADA filling lines at Lonza Basel and Visp (Project Dolfin and Project Orca). The equipment included the Bausch & Ströbel Filling Line 3 with OSI PI for eLog & eBR (approved by the full team of over 50 engineering specialists). My work as Validation Lead was thoroughly reviewed by SwissMedic and the FDA in 2024 and 2025 with no major findings.

I’m currently working as the CSV Lead on a SCADA line by Optima GmbH, wrapping up the Validation Plan. The company was audited by SwissMedic and the FDA last week, and we are still awaiting the final report. This assignment will end soon.

I am in the final stages of this validation work and open to a new challenge.

Languages

French
Native
Dutch
Native
German
Advanced
English
Advanced
Luxembourgish
Advanced
...and 4 more

Education

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PhD · Business Management

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MBA · International Business · Antwerp, Belgium

University of Gent

Mechanical Engineering · Ghent, Belgium

...and 1 more

Certifications & licenses

ISO Process Lead Auditor

SQS, Hilti Schaan, FL

ISO Process Auditor

SQS, Hilti Schaan, FL

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