Mark De Groof
    Managing Director

"Highly motivated and skilled project engineer with interesting project track record for high-end pharmaceutical companies, looking for opportunities to apply and broaden his scientific and technical knowledge to bring advanced engineering and qualification projects to a good end."


Master of Science in Bioscience Engineering (2011-2013)
Free University of Brussels
Grade: Magna cum laude

Master thesis: “Functional Affinity Improvement of Nanobodies for in vivo imaging of the β-cell population”

LanguagesDutch : Mother tongue
French : Basic skills
English : Fluent (both spoken and written)
German: Good (spoken)


Functional skillsChange / Deviation Management
ASTM E2500
Risk Analysis/Review
Secondary packaging processes
Root Cause Analysis
GMP Compliance
Process Improvements
SOP writing

Soft skillsProblem Solving
Result driven
Ambitious and Competitive
Social and Communicative
Eager to learn
Sense of initiative and responsibility

Technical skillsAntares Vision software
Lotus Notes
Windows Office (Word, Excel, PowerPoint, Outlook, Visio)
GraphPad Prism
Lab equipment software: HP300 Digital Dispenser, Envision, Applied Biosystems Viia7, Luminoskan Ascent, Cryo Manager, Meso Scale Discovery,)

Project Portfolio

Sanofi Specialty Care Operations, Geel (Nov 2016 – current):

  • Validation of Biopharmaceutical Process Equipment / Facilities / Utilities 
    • Buffer/Media Preparation/Hold Vessels
    • Distribution Headers / Valve Rings
    • Bioreactors
    • Purification / Chromatography Skids
    • HVAC
    • Freezer Rooms
    • ...
  • IQ Coordination
    • Planning
    • Follow-up
    • Punchlist
    • Review 

The Janssen Pharmaceutical Companies of Johnson and Johnson, Beerse (Jan 2016 – Nov 2016):

  • Qualification of secondary packaging equipment for serialization implementation (Print&Check, Bundle machine, case packer/palletizer)
  • Anti-counterfeit regulations
  • Serialization/aggregation implementation strategy for S-Korea, China, Brasil and S.Arabia
  • Antares Vision Software platform (Serialization)-Cognex
  • Write User Requirements, Qualification Protocols, Impact assessments
  • Packaging Engineering (commercial artworks, templates)
  • Study Electrical drawings
  • Factory Acceptance Testing (FAT)

Pfizer Manufacturing, Puurs (Feb 2015-Jan 2016):

  • Provide support to production department
  • Compliance review of equipment/processes – Audit Readiness
  • Risk Analysis (FMEA)
  • Introduction of 2D datamatrix printing on folding boxes (PCE vision system)
  • Process improvement handling of ejected/rejected cartons
  • Introduction Isolator/RABS Glove Management Program
  • In Process controls
  • CC / CAPA owner