About-me


I am an expert in the (process) automation and computer system validation (CSV), with 37 year experience in the pharmaceutical industry, I offer expertise, reliable advice and services as a project manager and/or project engineer, including computer system validation in complaince with the regulations.

For my work experience, see brief summary hereunder:

SUMMERY:
Total 37 year experience in the Pharmaceutical Industry, including GxP, GAMP and FDA regulations.
My knowledge & skills are mainly in the field of Project Management / Engineering in:
1. (Process) automation.
2. Manufacturing execution system (MES), production lines and packaging lines.
3. Automated warehousing and distribution systems.
4. Computer system validation in compliance with GAMP, cGxP and FDA regulations.

WORK EXPERIENCE:
2012 to June 2015: Teva Pharmachemie B.V. Haarlem as Director ICT.
The ICT department consisted of 18 employees.

Project references (some examples):
• Implementation and validation of Vendor Managed Inventory (VMI) system.
• Optimisation by virtualisation of the server park, cost effective and efficient to management aspects.
• Implementation and validation of a WMS system for Teva GPL Amsterdam.

1999 to 2012: Teva Pharmachemie BV Haarlem as Director ICT Technical Support.
The ICT Technical Support department consisted of 10 employees.

Project references (some examples):
• Upgraded and validated Empower HPLC architecture for the R&D and QC departments.
• Part-11 project, in collaboration with Production & QA.
• Implementation and validation of the Oracle ERP application.
• Hubble project, implementation and validation of a new BPCS ERP application.

1988 to 1999: Pharmachemie BV Haarlem as Manager Process automation and Engineering.
The Process automation and Engineering department consisted of 3 employees.

Project references (some examples):
• Project UIL, setting up URS, FS, IQ’s, OQ’s, PQ’s and SOP’s in collaboration with QA and Lachman.
• For the new construction, I became responsible for the design, budget, installation, testing and validation.
As project manager I was the contact point for e.g.:
– Water and steam treatment, HVAC’s, Cooling water, Particle counting system (PCS), several production lines e.g. IWKA.
– Complete new Warehouse Management System (WMS), including AGV’s, Conveyors, elevators and weighing systems.

1979 to 1988: MSD BV Haarlem as System Support Engineer.
I was responsible for the process and logistic automation.

Project references (some examples):
• Carried out various application modifications within the Warehouse system.
• New weighing and dosing system for Ivermectine Plant, completely automated with PC/PLC.
• Modification and optimisation for the Uhlmann blister lines, project “Rapid Tool Setting”.

PERSONALITY:
Persistent, flexible, enthusiastic, independent, strong analytical skills and a team player.

PREFERRED INDUSTRY:
Pharmaceuticals, Biotechnology and Food industry.

If required I can send you my complete CV on request.