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

ProjectsNew 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