Paul V. - CSV Lead

Wuermeldeng, Luxembourg

Experience

Jan 2025 - Dec 2025

1 year

Switzerland

CSV Lead

Optima GmbH

Working on a SCADA Line wrapping up the Validation Plan.
Managed validation processes recently audited by SwissMedic and FDA.

Jan 2022 - May 2023

1 year 5 months

Jena, Germany

CSV Lead

Carl Zeiss Vision

Managed CSV integration for Siemens Polarion, Avasis, and Azure.
Led a very large SCADA / Polarion / Siemens integration project involving over 10 interacting companies.

Jul 2021 - Dec 2025

4 years 6 months

Basel, Switzerland

Senior CSV Validation / QA / Data Integrity Expert

Lonza

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.

Jun 2021 - Sep 2021

4 months

Dessau-Roßlau, Germany

CSV Expert

Merz

CSV Expert for complex QC machines including refrigerators, ovens, UHPLC, rheometers, test benches, and gas chromatographs.

Feb 2021 - Dec 2021

11 months

Amsterdam, Netherlands

Ad Hoc / Short Term Consultant

Sanquin bv

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.

Jan 2021 - Jun 2021

6 months

Neuenburg am Rhein, Germany

Consultant

Nemera

Adapted technical specifications according to 21CFR820 to meet USA and EU non-civil norms for a mass-produced injection product.

Feb 2020 - May 2020

4 months

Frankfurt am Main, Germany

Data Integrity Expert ALCOA

Sanofi

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.

Oct 2019 - Jan 2020

4 months

Neuenburg am Rhein, Germany

Consultant / Trainer

Nemera

Provided training on all 125 GMP critical SOPs (HerstellAnWeisungen and PrüfAnWeisungen) for the full QC staff across 77 group trainings.
Systematically updated SOPs where needed.

Sep 2019 - Sep 2020

1 year 1 month

Lessines, Belgium

Senior Computerized Systems Validation Expert

Takeda Shire Baxter

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.

Jun 2019 - Oct 2019

5 months

Aalen, Germany

Study Lead UDI Strategy

Carl Zeiss Vision

Consultant on Unique Device Identification (UDI) of lenses and optical devices.
Developed position paper on UDI introduction for prescription glasses.

May 2018 - Apr 2019

1 year

Munich, Germany

TMV / CSV Engineer

LivaNova

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.

Mar 2018 - Dec 2018

10 months

Wevelgem, Belgium

CSV Manager

Janssen Vaccines & Prevention (Johnson & Johnson)

CSV Lead of all QC Excel sheets.
Managed CSV preparation for Waters/Empower HPLC and Shimadzu systems.

Sep 2017 - Jul 2018

11 months

Zofingen, Switzerland

CSV & Data Integrity Manager / Consultant

Arena Pharmaceutical / Siegfried Pharmaceutical

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

Aug 2017 - Jan 2018

6 months

Darmstadt, Germany

Senior Computerized Systems Validation Expert Pharma

Merck KGaA

CSV lead for the Project Eldorado Successor involving a fully new design of a Document Management System followed by full CSV.

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)

Authored full documentation for the LIMS IT Data Migration Project (55To).
Managed data integration and equipment acceptance validation for the transfer of databases from Novartis Vaccines into GSK Vaccines, including Agilent eLabNoteBooks and Labware.

Apr 2014 - Apr 2016

2 years 1 month

Umkirch, Germany

CSV / TMV / Qualification IT Project Lead

Johnson & Johnson (Synthes Surgery Mechanics)

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.

Apr 2013 - Dec 2013

9 months

Basel, Switzerland

CSV Expert

Novartis IT ChemOps

CSV Expert and Requirements Engineer for Manufacturing Execution Systems (MES) including historian.
Worked across sites in Sankt Johann, Stein, and Schweizerhalle using Novartis software.

Jan 2011 - Sep 2025

14 years 9 months

Hong Kong

Translator

Jakks Pacific

Regularly translate toy portfolios into all European languages.

Jan 2011 - Dec 2012

2 years

Künzelsau, Germany

BMP Business & Logistics Analyst

A. Würth GmbH & Co KG

Analyzed business processes and logistics.

Jan 2008 - Dec 2010

3 years

Belgium

Freelance Contractor

European Commission

Provided IT help desk support to the Directorate-General for IT.

Jan 2008 - Dec 2009

2 years

Brussels, Belgium

Customer Satisfaction Analyst

Lexus

Developed 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

Conducted a strategic analysis on the sustainability of the institute's language courses.

Jan 2007 - Dec 2013

7 years

Belgium

Freelance Interpreter / Translator

European Commission

Provided linguistic services to the Directorate-General for Expansion.

Jan 2007 - Dec 2007

1 year

Brussels, Belgium

Consultant / Linguist

Worldbank

Performed multiple consulting and linguistic tasks during the presidency of the European Council.

Jan 2005 - Dec 2010

6 years

Brussels, Belgium

Free-lance Contractor

Serco Ltd / SA

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.

Jan 2005 - Dec 2006

2 years

Lyon, France

Translator

Mastic Olin SA

Translated the full product catalogue into 4 languages.

Jan 2004 - Dec 2005

2 years

Ghent, Belgium

Customer Relations Analyst

Insurance Brokerage Group Willemot

Conducted customer relations analyses.

Jan 2004 - Dec 2005

2 years

Fridolfing, Germany

Developer

Otto Chemie

Developed SQL algorithms and a linguistic database for over 10 languages for all Product Data Sheets.
Translated approximately 120 TechDoc positions in 5 languages.

Jan 2003 - Sep 2025

22 years 9 months

Luxembourg

Process Management / Engineering / IT Contractor

JUMA23 Center for Business & Linguistic Excellence

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

Jan 1993 - Dec 2003

11 years

Liechtenstein

Product Manager / Global Project Leader

Hilti Befestigungstechnik

Product Manager for approximately 700 products in 27 countries.
Global Project Leader for Corporate Business Excellence and KPI Customer Perfect Order across 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

Performance Consultant

Hayek Engineering

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

Oct 1986 - Jan 1988

1 year 4 months

Geneva, Switzerland

Management Trainee / Market Development Engineer

Caterpillar Overseas

Served as Market Development Engineer in the Engine Marketing Department.

Oct 1981 - Dec 1984

3 years 3 months

Germany

Project Manager

Blumhardt Fahrzeugwerke BRD

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.

Summary

Based on my profile, see please hereunder, I should like to express my interest. Herewith some notes on my career.

Status: I handled 2023 – 2025 the Validation Plan as the SGIE Val Expert of 2 SCADA Filling lines @ Lonza Basel and Visp (Project Dolfin, Project Orca). The equipment was Bausch & Ströbel Filling Line 3 incl. OSI PI for the eLog & eBR (approved by the full team >=50 engineering specialists). My work as Validation Lead was thoroughly scrutinized in 2024/2025 by Swiss Medic and FDA with no major findings.

I am currently working, also in Switzerland, on another SCADA Line by Optima GmbH also as the CSV Lead wrapping up the Validation Plan. Last week, the company was audited by SwissMedic and FDA results / report now still outstanding. This assignment halts in the near future.

I am currently in the late phase of my Val work, so I am open for a new challenge.

I support pharmaceutical companies worldwide in various CSV/SGIE/TMV/DI/recently QA projects for LIMS, Data Management Systems projects up to personally getting involved in FDA (2 projects), Regionales Heilmittelinspektorat Basel audits, Instant Readiness audits and a 3 days Validant Data Integrity audit.

I gained extensive CSV Engineering knowledge of the pharmaceutical industry as per mainly DIN13485 in my roles as Subject Matter Expert, project manager, information analyst to executive engineer and QA auditor.

More practical details: Time Management, Glasswalls, Gemba Walks, Stand-up meeting, continuously ensuring buy- in for quality purposes, cockpit charts to monitor progress and issues, always lead to fully acceptable and signed off CSV/DI documentation, since very many years in my case.

Skills

Csv / Sgie Project Leadership: Led And Managed Csv / Sgie Strategic Growth And Investment Engineering Activities For Manufacturing And Lab Systems In Highly Regulated Environments (E.g., Fda, Din13485 Compliance).
Regulatory Compliance & Quality: Extensive Experience With Fda, Iso 13485, Gmp, And Data Integrity Audits; Zero Findings In Fda Audits At Lonza And Arena.
Validation Documentation: Author Of Validation Plans, Test Protocols (Iq/oq/pq), Traceability Matrices, And Requalification Documentation For Complex Lab Systems (Hplc, Solo Vpe, Ice, Etc.).
Extensive Experience With Sterilizations And Clean Rooms.
Cross-functional Team Coordination: Coordinated Test Execution Across It System Owners, Stakeholders, And Testing Teams, Ensuring Timely Validation Deliverables And Compliance.
Experience With Lab Systems: Managed Validation For Lims, Eln, Cds Systems (Labware, Thermo Fisher Watson, Empower Waters).
Regulatory Experience: Led Fda Audits, Worked On Udi Projects For Carl Zeiss, And Involved In Regulatory Filings For Medical Devices (E.g., Gsk, Takeda, Merck).
Agile & Waterfall Methodologies: Hands-on Experience Working With Scrum, Agile, And Waterfall In Csv Project Settings.
Experience With Agile Frameworks: Csv: Scrum, Agile, Waterfall; Personally Working Intensively In An Agile Mode.
Personal Strengths: Strong Team Player / Strong Communication Skills / Enthusiasm For Other Cultures / Flexibility / Leadership Ability / Out Of The Box Thinking / Analytical Skills / Creativity.
Soft Skill Set: Outspoken, Multicultural, Multilingual, Result Oriented In Complex Matrix Organizations, Strong Problem-solving Abilities Incl. Coaching And Training.