Cleaning Validation Expert - Life Sciences Sector
Functieomschrijving
About Akkodis: Akkodis is a global digital engineering company and Smart Industry leader. We enable clients to advance in their digital transformation with Talent, Academy, Consulting, and Solutions services. Our 50,000 experts combine best-in-class technologies, R&D, and deep sector know-how for purposeful innovation. We are passionate about Engineering a Smarter Future Together. Functieomschrijving: We are actively looking for an expert in Cleaning Validation to support the activities of one of our customers, operating in the Life Sciences industry.
You are specialized in different cleaning technologies across the whole spectrum: from manual to automated cleaning and works in a team with other cleaning validation engineers. As a cleaning validation engineer, you focus on 1 or 2 specific parts of production operations department becoming an expert and first point of contact for all cleaning related projects and issues in that specific part of the site. You have a deep technical understanding of the cleaning processes (hardware, software, … ) together with the needs and issues that production is facing. The positions supports all cleaning aspects of 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, …). You also handle deviations and production emergencies to guarantee operational continuity. To remain compliant, your scope includes periodic processes (paper based reviews and actual sampling programs).
Profiel
Profiel: You hold a Scientific Degree equivalent to Master (Pharmaceutical Sciences, Bioengineer, Industrial Engineer, …);
You have a proven experience of at least 3 years in Validation and/or Project management in a GMP production environment. An experience in cleaning validation is a clear asset.
You have a hands-on experience in a regulated pharmaceutical manufacturing environments with a flexible attitude.
You have developed knowledge on operating principles of cleaning and CIP processes is a huge plus
You are a good communicator, able to adapt to a wide range of profiles (from operators on the shopfloor to IPT directors to report progress)
You have an analytical approach and mindset and take your decisions based on proven data.
You are fluent in both Dutch and English (verbal and written)
Homebased work is possible for max 2 days + in consultation with co-workers