Pharma & Biochemical experience +10 years
2017 - 2018 Bio Base Europe Pilot Plant @ Gent
Sector: Service provider for process development, scale-up and custom manufacturing of biobased products and processes
Role: Project Manager
Projects: Solvent storage tanks; 2nd aircompressor clean air; Chilled water system; Vacuum liquid ring pump
Type of projects: CAPEX - EPC - Green and Brown field
Disciplines: Piping; Mechanical; Instrumentation; Electricity; Automation; Civil; Structural; Process; Process Equipment
Tasks & Responsibilities
Solvent storage tanks & distribution through switch board: For operational and safety reasons 4 new solvent storage tanks were put in place instead of use of IBC's. (unloading area/tankpit/N2-blanketing/EVD Explosion protection document and zoning file acc. to ATEX 137
Detailed Design/PID/Technical specifications/Process and technical calculations; Cost control; Planning (tasks, internal and external resources); Construction follow-up; Commissioning; Start-up and fine-tuning; As-built and Hand-Over; VLAREM approval
Close working relation with: Subcontracted construction companies civil/structural; piping; tracing/insulation, electrical, instrumentation and automation; Supplier of storage tanks; Bureau for ATEX certification and compliance
2nd aircompressor clean air: Redundancy and upscaling capacity compressed air/clean air
Detailed Design/PID/Technical specifications/Process and technical calculations; Budget estimation/Cost control/ROI and planning; Price bids and comparison + Q/A (with Procurement); Construction follow-up; Commissioning; Start-up and fine-tuning; As-built and Hand-Over
Close working relation with: Subcontracted construction companies piping, electrical, instrumentation and automation; supplier of compressor-absorption filters-buffer
Chilled water production and distribution system:
Study; Concept; Detailed Design/PID/Technical specifications/process and technical calculations; Budget estimation/ROI and planning; Construction follow-up; Commissioning; Start-up and fine-tuning; As-built and Hand-Over
Close working relation with: Subcontracted engineering - architect company (civil/structural); construction companies civil/structural; piping; electrical, instrumentation and automation; supplier of compressor-absorption filters
Vacuum liquid ring pump: Recuperation of solvent with vacuum/condensation effect
Concept; Detailed Design/PID/technical specification/Budget control and planning; Procurement of all parts; Construction follow-up; Commissioning; Start-up and fine-tuning; As-built and Hand-Over
Close working relation with:
- Biobase TS, Operations and SHE
- Construction companies piping, electrical, instrumentation and automation
Codes and standards: according to DIN; ATEX; PED; VLAREM; ATEX; Bio Base Standard Procedures
2015 - 2016 Janssen @ Beerse
Sector: Pharmaceutical Company
Role: Project Manager
Projects
Janssen Beerse Liquids & Creams: Sorbitol Project; Replacement Holding Tank 5T=>10T; NPV Holding tanks shampoo;
Janssen Olen Chemische Productie: Overfill protection/level measurement tankfarm (Methyleenchloridetanks, ethanoltanks en niet-recup solvent tank) at Janssen Olen
Type of projects: CAPEX - EPC - Green and Brown field
Disciplines: Piping (black & clean utilities); Mechanical; HVAC; Instrumentation; Electricity; Automation; Civil; Structural; Process; Process Equipment; Fire Safety
Tasks & Responsibilities
Sorbitol project: Appointed as the new Project Manager (replacement) - stage project: construction phase; Review Technical Specifications; Planning (tasks, internal and external resources); Construction follow-up; Pre-commissioning and Commissioning; Qualification and Validation; As-built and Hand-Over, SHE - and FAGG approval
Close working relation with: Subcontracted engineering office, construction companies civil/structural, piping, instrumentation, automation; supplier of storage vessels; Janssen technical, operations, qualification and SHE departments
Replacement Holding (stirring) Tank 5T=>10T: Detailed Design/PID/technical specification/Budget control and planning; Price bids and comparison + Q/A (with Procurement); Construction follow-up; Commissioning; Qualification and Validation; As-built and Hand-Over
Close working relation with: Subcontracted construction companies civil/structural, piping, instrumentation, automation company; supplier of vessels; Janssen technical, operations, qualification and SHE departments
NPV Holding tanks shampoo: Study; Concept; Detailed Design/PID/technical specification/process and technical calculations; Budget estimation/ROI and planning; Price bids and comparison + Q/A (with Procurement)
Overfill protection/level measurement tankfarm (Methyleenchloridetanks, ethanoltanks en niet-recup solvent tank): Concept; Detailed Design/PID/technical specification/Budget control and planning; Price bids and comparison + Q/A (with Procurement); Construction follow-up; Commissioning; Qualification and Validation; As-built and Hand-Over
Close working relation with:
- Janssen Management (CEO & Directors)
- Janssen TS black and clean, Operations, SHE and QA
- Subcontracted engineering office (Sorbitol project)
- Construction companies piping, instrumentation and automation
Codes and standards: according to DIN; ATEX; PED; cGMP; CAPA; GAMP; Eudralex; Janssen Standard Procedures
2015 Launch/start of a new DPS Engineering Office @ Mechelen
Sector: Pharmaceutical Engineering Company
Role: Sr. Project Manager and Business Development
Results: First contract win for DPS Belgium at GSK Wavre, LVV Remediation project WN281-W27
Type of projects: CAPEX - EPCMV - Brown field
Disciplines: All disciplines, Clean rooms, Black & Clean utilities; Process; HVAC; Instrumentation; Electricity; Automation; Civil; Structural; Process Equipment; Qualification and Validation; Document control; Fire Safety
Tasks & Responsibilities
Project Execution Plan (PEP); Project Scope; Quality Controls; Environmental, Health and Safety; Project Management; Project Controls; Design Management; Construction Management Plan, Commissioning and Qualification Plan
Basic Design (incl. list of deliverables); Detailed Design; Procurement; Construction, CQV; Document Distribution Matrix; Team Progress Meetings; Project Review Meetings; Design Meetings and/or Construction Meetings; Safety Meetings; Daily Coordination Meetings; Steering Committee Meetings; FAT/SAT Testings; Punch Lists; Change Management;
Close working relation with:
- DPS Engineering Europe
- GSK Project team
Codes and standards: according to ASTM; ASME; DIN; PED; cGMP; CAPA; GAMP; HAZOP; DPS & GSK Standard Procedures
2012 Lonza @ Braine L'Alleud
Sector: Pharmaceutical Company - Production of Peptides
Role: Project/Process Engineer
Projects
Air Emission Handling Phase 2 (AEH2) H1 Building => from open process to closed process, re-routing of clean – and black utilities and random adjustments of existing reactors and cristallisators
Problem solving for Technical Services: Broken heat exchanger due to water hammer; Condensate return collecting vessel issue
Type of projects: CAPEX - EPC - Brown field
Disciplines: Piping (black & clean utilities); Mechanical; Instruments; Process; Process Equipment
Tasks & Responsibilities
Technical Specifications; Valve, Instrument and Equipment lists; PID; Planning (tasks, internal and external resources); Price bids and comparison + Q/A (with Procurement); Construction file and follow-up; Decommissioning E&I/Utilities; Pre-commissioning and Commissioning; Qualification (IQ and OQ); Shutdowns and Start-up; As-built and Hand-Over
Close working relation with:
- Lonza Project team
- A team of designers
- Different suppliers and construction companies piping/instrumentation and equipment parts
Codes and standards: according to DIN; ATEX; PED; cGMP; Eudralex; Lonza Standard Procedures
2010 - 2011 Ajinomoto Omnichem @ Wetteren
Sector: Contract manufacturer of fine chemicals for the Pharmaceutical Industry
Role: Project Engineer
Projects
New airlocks to prevent cross-contamination; Replacing a crusher for grinding large blocks of product; Redesign of heating circuits of two reactors due to simultaneous use; Analysis of explosion damage due to runaway; Process optimization reflux reactors.
Type of projects: CAPEX - EPC - Brown field
Disciplines: Piping (coated, glass and non-glass); Mechanical; HVAC; Instrumentation; Automation; Civil; Process; Process Equipment; Fire Safety
Tasks & Responsibilities
Building 428 - New airlocks to prevent cross-contamination: Study; Concept; Detailed Design/PID/Technical specification/Process and technical calculations; Budget estimation/ROI and planning; Price bids and comparison + Q/A (with Procurement)
Civil; Fire Safety; Modification of the existing HVAC installation; HVAC pressure/segregated zones calculations/layout; Integration of the airlock monitoring into the visual network
Building 428 - Replacement crusher large blocks: Detailed Design/PID/Technical specification; Price bids and comparison + Q/A (with Procurement)
Building 307 - Redesign heating circuits of two reactors due to simultaneous use: Study; Concept; Detailed Design/PID/Technical specification/Process and technical calculations; Budget estimation/ROI and planning; Price bids and comparison + Q/A (with Procurement)
Synthese SY4B and 5 - Analysis of fire damage due to runaway/explosion: Inventory and budget estimation for the building, equipment (scrubber, enamelled reactor vessels and heat exchangers), piping (glass and non-glass piping), instrumentation and electricity
Synthese building - Process optimization reflux reactors : New Condenser design; Study; Concept; Detailed Design/PID/Technical specification/Process and technical calculations; Budget estimation/ROI and planning; Price bids and comparison + Q/A (with Procurement)
Codes and standards: according to ASTM; ASME; DIN; ATEX; PED; cGMP; Ajinomoto Omnichem Standard Procedures
2004 - 2008 GSK @ Rixensart
Sector: Pharmaceutical Company
Role: Process Engineer
Projects
Revamp RX 157 project building RX46; SPIP projects
Type of projects: CAPEX - EPCMV - Green and Brown field
Disciplines: Clean utilities; Instrumentation; Electricity; Automation; Civil; Structural; Process Equipment
Tasks & Responsibilities
Building RX46 Revamp RX 157 project: This project consist of Formulation - and HIB - parts and were split into two main phases, Phase 1: B46 – GMP Improvement (part of level 0 and level 2), Phase 2: B46 level 2 – Facility improvement & capacity increase + SB62 project CIP/SIP Mobile vessels system. The Filling area was not included in the RX157 project (other project).
SPIP (small pharmaceutical improvement projects): New autoclave incl. building/room adaptations, Five (5) new mobile vessels with agitator, Mobile vessel VS-3001 for mixing oil components, New Compressor for clean air, etc.
For both:
Study; Concept; Detailed Design/PID/Technical specification (review)/Process and technical calculations; Budget estimation/control and planning; Price bids and comparison + Q/A (with Procurement); Construction file and follow-up; Decommissioning E&I/Utilities; Change control/variation order management; Pre-commissioning and Commissioning; Qualification (IQ, OQ, FAT, SAT, EAT); Shutdowns and Start-up; As-built and Hand-Over
Close working relation with: A team of designers (layouts, isometrics, overall isometrics); Construction company (piping/instruments); Supplier of equipment and equipment parts
Systems/equipment: Deionized water EDI production and distribution; Water for injection production (distiller, storage vessel) and distribution; Clean Steam Generation and distribution; Compressed air production and distribution for clean air; Non contaminated and contaminated waste water systems (pressurized and non-pressurized); Cold softened water; CIP/SIP systems; Autoclave IQ/OQ incl. temperature mapping and load/bacteriology-validation
Close working relation with:
- GSK Project team
- GSK TS and Operations
- A team of designers
- Different suppliers and construction companies piping/instrumentation and equipment
Codes and standards: according to ASTM; ASME; DIN; PED; cGMP; GAMP; CAPA; Eudralex; GSK Standard Procedures
2004 Janssen @ Beerse
Sector: Pharmaceutical Company
Role: System Qualification Engineer
Projects: Autoclave Sauter 1 & 2; Balansen Formulation Liquids & Creams; HAMO Cleaning, Desinfecting and Drying System for Containers; CIP/SIP 2.0
Type of projects: CAPEX
Description:
Janssen Beerse received a FDA483 warning letter for the sterile section.
Actions needs to be done: Review of the changes, the as built documents and the validations of equipment and systems. Together with the PSQR of the technical aspects and the PSQR of the GMP aspects, it constitutes an examination of the qualified status of the system.
Tasks & Responsibilities
Critical analysis of the equipment/system; Assesments qualification status
Verification of URS & SRS
Functional Specification/Detailed description/PID/Approved design drawings/Program description
Installation instructions/SOP's
VMP, IQ, OQ, PQ, PV and CSV
Periodic validations (cleaning validation, thermal validation; DOP tests, particles counting, etc.)
Verification of the Change Control Management/Open actions (GAP's)
Summary reports DQ/IQ/OQ/PQ; Evaluation requalification
Close working relation with:
- Janssen TS and Operations
Codes and standards: according to cGMP; CAPA; Eudralex; Janssen Standard Procedures
2003 - 2004 GSK @ Rixensart
Sector: Pharmaceutical Company
Role: Sr. Validation Engineer
Projects: New Medical Devices; Parametric Release; Sterilization wrap; Isolator port/entry; PQ equipment and systems
Type of projects: CAPEX
Tasks & Responsibilities
New Medical Devices:
Injection apparatus without needle - Design Qualification Program inluding research, testing, evaluation, analysis, summary report DQ
Parametric Release:
Analysis and evaluation that parametric release could be a solution to avoid a time-cosuming sterility test for the production of Water for Injection (WFI). Parametric Release however involves utilizing information collected during the manufacturing process to demonstrate that the product was made according to defined GMP and sterilization procedures.
Sterilization Wrap:
Analysis and evaluation of Sterilization Wraps during steam and ethylene oxide sterilization processes.
The Sterilization Wrap is to create a sterile barrier against bacteria for terminally sterilized medical devices
Isolator port/entry:
Analysis and evaluation of a secure interlock for isolators that enables material to be moved from one sterile zone to another through a non-sterile zone, with leak-tight, risk-free reconnection.
PQ equipment and systems:
Writing/executing PQ's with results/conclusions for different devices/equipment such as a washing machine, autoclave (thermo mapping), mobile vessels, isolators (VHP), HVAC (DOP test, AIr flow pattern, etc.) & CIP/SIP
Codes and standards: according to cGMP; Eudralex; GSK Standard Procedures
2002 - 2003 Federa @ Neder-Over-Heembeek
Sector: Pharmaceutical Company - Filling of Syringes, Ampoules and Auto-Injectors
Role: Validation Coordinator
Project: New stand - alone filling facility
Type of projects: CAPEX - EPCMV - Green field
Disciplines: Clean rooms, Clean utilities; Process; HVAC; Automation; Process Equipment; Qualification and Validation; Document control
Tasks & Responsibilities
Business URS; URS's for all equipment and systems
Validation Master Plan (VMP); Cleaning Validation Master Plan; Co-redaction Process Validation Master Plan
Facility Design Qualification
Project Validation Policy
Project implementation Test Concept
Qualification protocols IQ, OQ, FAT, SAT & EAT
Overall project planning for engineering, qualification and Validation activities
For the following systems/equipment:
Clean rooms; Filling machines; HVAC; Warehouse/Cold Storage; Autoclave; Washing machines; CIP/SIP
Deionized water EDI production and distribution; Water for injection production (distiller, storage vessel) and distribution; Clean Steam Generation and distribution; Compressed air production and distribution for clean air; Non contaminated and contaminated waste water systems (pressurized and non-pressurized); Labo gasses
Close working relation with:
- Federa Management
- Federa QA and Engineering
Codes and standards: according to ASTM; ASME; DIN; PED; cGMP; Eudralex; Federa Standard Procedures
2001 - 2002 CAF-DCF @ Neder-Over-Heembeek
Sector: Pharmaceutical Company - Plasma Fractionation for the production of plasma-derived products
Role: Site Manager - Project Engineer
Projects: New stand - alone Plasma Fractionation Plant
Type of projects: CAPEX - EPCMV - Green field
Disciplines: Clean rooms, Black & Clean utilities; Process; HVAC; Instrumentation; Electricity; Civil; Structural; Automation; Process Equipment; Qualification and Validation; Document control
Tasks & Responsibilities
Study; Concept; Detailed Design/PID/Technical specification (review)/Process and technical calculations; Budget estimation/control and planning; Price bids and comparison + Q/A (with Procurement); Construction file and follow-up; Change control/variation order management; Pre-commissioning and Commissioning; Qualification (IQ, OQ, FAT, SAT, EAT); Shutdowns and Start-up; As-built and Hand-Over
Close working relation with: Engineering Office (Building/Clean rooms); Architect; Civil Contractor; Suppliers of equipment and equipment parts; Construction Companies Black and Clean Utilities
Building: Concept Administration/Production/Labo sections - Clean rooms - HVAC - Fire Safety
Black services: Steam generator; Ethanol Unloading/Storage; Natural gas; Waste Water Treatment; Chilled water; Ice water; Compressed air; Nitrogen; Cold softened water;
Clean services and equipment: CIP/SIP systems; Autoclave; Deionized water EDI production and distribution; Water for injection production (distiller, storage vessel) and distribution; Clean Steam Generation and distribution; Compressed air production and distribution for clean air; Non contaminated and contaminated waste water systems (pressurized and non-pressurized)
Close working relation with:
- CAF-DCF Management
- CAF-DCF QA
- Different suppliers and construction companies piping/instrumentation, equipment
Codes and standards: according to ASTM; ASME; DIN; PED; GMP; Eudralex; CAF-DCF Standard Procedures
2000 - 2001 GSK @ Wavre
Sector: Pharmaceutical Company
Role: Process/Validation Engineer
Projects: RX83 MEF
Type of projects: CAPEX - EPCMV - Green field
Disciplines: Clean utilities; Process Equipment; Qualification and Validation; Document control
Tasks & Responsibilities
Construction file and follow-up; Pre-commissioning and Commissioning; Qualification (IQ, OQ, FAT, SAT, EAT); Start-up; As-built and Hand-Over
Close working relation with: Drawing Office (Layouts, isometrics, overall isometrics); Suppliers of equipment and equipment parts; Construction Companies Clean Utilities
Black services: Cold softened water;
Clean services and equipment: CIP/SIP system; Deionized water EDI production and distribution; Water for injection production (distiller, storage vessel) and distribution; Clean Steam Generation and distribution; Compressed air production and distribution for clean air; Non contaminated and contaminated waste water systems (pressurized and non-pressurized); Process gasses
Close working relation with:
- GSK Project team
- A team of designers
- Different suppliers and construction companies piping/instrumentation and equipment
Codes and standards: according to ASTM; ASME; DIN; PED; cGMP; Eudralex; GSK Standard Procedures