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:

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.

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”.

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

Pharmaceuticals, Biotechnology and Food industry.

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