Automation Validation Technician (m/f)

AUTOMATION VALIDATION TECHNICIAN (m/f)

Function:

The Automation Validation Technician prepares and performs validation activities in order to ensure that Janssen's facility and production systems are validated according to regulatory and GPSG standards.

Responsibilities:

The Validation Technician is responsible to ensure that the validation team tasks are delivered with the right quality on the right time which includes:

* Performing FAT, SAT, commissioning IOQ excution of automated systems for: Process equipment, Utilities, Automation systems in general.
* Providing base business validation support in solving events, NC's and CAPA's.
* Training of colleagues and contractors in the validation activities.
* Maintaining and improving the Validation process in particular automated systems.
* Participation in preparation of cGMP inspections.
* It is the Validation Technician's responsibility to observe the necessary caution and carefulness in order to avoid dangers for the safety or health of themselves or others and for the environment, when carrying out activities. This implies eg that machines, apparatus, tools, dangerous compounds, transportation means and other expedients must be used properly, when necessary with use of the prescribed protective means.
* The Validation Technician shall not change or remove installed safe guards and will use them in a safe way. The jobholder immediately acknowledges management of dangers for the safety, industrial hygiene and the environment. Furthermore the jobholder should adhere to all safety, industrial hygiene and environmental procedures.

Requirements:

* MBO or HBO level in a IT/AT or technical education.
* Relevant courses of cGMP, GAMP5 and CFT part 11 and validation.
* At least 2 years experience within (bio-) pharmaceutical or related industry.Michael Bailey International is acting as an Employment Business in relation to this vacancy.