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."
| Education
| 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” |
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| | Languages | Dutch : Mother tongue
French : Basic skills
English : Fluent (both spoken and written)
German: Good (spoken) |
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Skills
| Functional skills | Change / Deviation Management
Qualification
V-model
ASTM E2500
Risk Analysis/Review
Secondary packaging processes
Automation
Root Cause Analysis
GMP Compliance
Process Improvements
SOP writing
GAMP5 |
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| | Soft skills | Problem Solving
Result driven
Ambitious and Competitive
Social and Communicative
Eager to learn
Sense of initiative and responsibility |
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| | Technical skills | Antares 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,)
TrackWise |
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
- 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
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