Computer Systems Validation

Job Title : Computer Systems Validation
Job Location : Puurs, BE
Job Duration : 9 months

Role profile

• Since our production departments are experiencing strong growth, the surrounding processes that ensure the supply of raw materials and materials to the production departments also have to evolve.
• In this context, the "Plant Logistics" project was started up, which will provide a new Logistics Center, a fully automatic high-bay warehouse and automation of the supply and introduction of materials in the sterile production.
• In this way we get more efficient material flows and we can proceed to a "just-in-time" delivery to production.
• Engineer Logistic Systems fits within this new project.
• All logistic functions will be centralized in the Logistics Center. In this Logistics Center the goods will be received and prepared for storage in the high-bay warehouse. From there the goods will then be transported to the production departments by means of AGVs (automated guided vehicles), and there they will be brought in via specific equipment in the cleanrooms. This equipment is divided into different packages, and each package needs its specific follow-up.
• The Warehouse Management System is called IPL and is managed by an IT team together with the users.
• The consultant we are looking for is on the user side.

What is expected from the consultant:
- In the first weeks, the consultant must learn the following: the IPL system, the material flow, the tasks of the department, the content of the project.
- In the second instance, the third party is expected to prepare the test scripts on the basis of the regulations.
- Performing the test scripts in a test environment, then in a validation environment, with the format of accompanying test evidence.
- Prepare documentation, prepare the work instructions for the operators (i.e. explain procedures and pass on information to the person in charge of the work instructions).
- Training / explaining to the users and key users
- Works closely with the training department: how to deregister instructions, discuss content and effectively deregister and create the links in the system (eg Which training for which function apply for new starter)
- Prepare for implementation and start-up
- Operational aftercare after start-up

Profile:
- experience with validation of computer systems
- Nice to have: Pharma experience (GMP, Pharma regulations)
- Languages: Dutch + English.
- Test documents are in English.
- Contact with suppliers is in English.
- Dutch will be used with the operators.

Personal Skills:
- Communicator: can communicate at all levels,
- Technical Writer: can develop procedures that are relevant, clear and applicable
- Stress resistant

Shift: day with flexibility to shifts is necessary.