Process Validation Engineer - Pharmaceutical - Holland

Biopharmaceutical Contract Manufacturing Organisation based in Holland have a contract requirement for an experienced PROCESS VALIDATION ENGINEER.

We are looking for a Process Validation Engineer to look at existing validation processes, work on a new project with a new client & product with production ideally to be ready for August.

To be successful for this project we are looking for the following:

Requirements:
Process Validation

- Pharmaceutical/Biotech background and experience of - at least - a couple of years in validating biotech process equipment.

Duties:

- Perform qualifications and re-qualifications supporting biopharmaceutical manufacturing .
- Write and execute installation and operational (IOQ) protocols and summary reports.
- Review and approve validation documentation.

Any of the following experience advantageous:

- Equipment Commissioning
- Cleanroom Qualification
- Autoclaves
- Clean Steam
- Cleaning In Place (SIP)
- Water for Injection (WFI)
- Refrigerators and Freezers (TCU's)
- HVAC-systems
- Incubators and Ovens
- Bio Processing systems (with PCs).

CSV experience would be highly advantageous.