Description:
The Cleaning Validation Engineer is key in the development, validation and improvement of the cleaning processes for EQUIPMENT AND TOOLS (not environment).
He / she specializes in different cleaning technologies across the whole spectrum from manual to automated cleaning and works in a team with other cleaning validation engineers.
In practice, the cleaning validation engineer typically focusses on 1 or 2 specific parts of the Heist Production Operations becoming an expert and first point of contact for all cleaning related projects and issues in that specific part of the site.
He / she is expected to DEEPLY UNDERSTAND ALL TECHNICAL ASPECTS of the cleaning processes (hardware, software, … ) together with the needs and issues of Production.
The role supports all cleaning aspects of exciting new product / equipment introductions and takes the lead in realizing pro-actively and reactively significant cleaning related improvements of existing processes. This includes using the change control system, writing plans, protocols and reports and executing the studies (taking samples, coordinating with the labs, …).
The cleaning validation engineer also handles deviations and urgencies in PRODUCTION to ensure operational continuity. Although this is not every week, this requires a certain degree of flexibility from time to time (change in day planning, come to the site when working from home, doing overtime or early/late shift, … ).
To remain compliant, cleaning validation also includes periodic processes (paper based reviews and actual sampling programs) in which the engineer plays it’s role.
And last but not least, in time, the cleaning validation engineer is recognized for his / her expertise and can be asked to be the site topic lead, participating in above site teams with other cleaning validation experts.
Your Profile:
* Higher Scientific Degree (Pharmaceutical Sciences, Bioengineer, Industrial Engineer, …);
* At least 3 years of relevant experience in Validation and/or Project management in a GMP PRODUCTION ENVIRONMENT (not LAB environment) – in cleaning validation is off course a HUGE PLUS and almost a must have !
* Hands-on experience in a regulated pharmaceutical manufacturing environments with a flexible attitude (sporadically an early or late shift, extra hours, weekend work to support business continuity of our production processes)
* Knowledge on operating principles of cleaning and CIP processes is a huge plus
* Analytical mindset and Project-minded;
* Excellent communication skills to work effectively with a range of workers (from operators on the shopfloor to IPT directors to report progress)
* Teamplayer
* On-the-floor approach;
* Customer focused;
* Outstanding Influencing skills;
* Process and data driven;
* Problem solving skills to investigate failing validation data
* Fluency in both Dutch and English (verbal and written)