Process Validation Engineer

Development, validation and implementation of decontamination processes Creation of test protocols and test reports Enabling customer-orientated decontamination processes with maximum safety and efficiency Process optimisation and requalification of existing processes as well as customer-oriented troubleshooting and consulting Carrying out internal and external training for customers Supporting cross-functional technological improvements and innovations Assisting with the maintenance, updating and improvement of internal SOPs, documentation and workflows

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organization have made SKAN a market leader and a key partner to industry and research laboratories. We are looking for a motivated Process Validation Engineer (PVE) for the Process Validation Microbiology (PVM) department. The PVM team consists of professionals with a wide range of cultural, academic and professional backgrounds. Our team specialises in the development and validation of decontamination processes (H2O2 and E-Beam) for pharmaceutical isolators, which are a key element in the aseptic manufacturing of sterile drugs. As a member of this team, you will have the opportunity to travel worldwide to support our pharmaceutical customers in their life-saving projects. This role therefore involves up to 50% international travel to our customers.

• A university degree (Bachelor's or Master's) in life sciences, engineering or technology is required

• Experience in one of the sterilisation technologies (steam, irradiation or ETO) and/or isolator decontamination (H2O2 and/or e-beam) is very welcome

• Experience in cleanroom qualification in the medical device and/or pharmaceutical industry is also appreciated

• Experience in process validation (IQ/OQ/PQ) is an advantage

• Very good knowledge of English is required, any other foreign language is a plus

• You have a professional, reliable way of working, especially for customer contact (internal and external) and can take on personal responsibility

• Furthermore you are a motivated person who likes to work carefully and in compliance with GMP

• You are comfortable dealing with different cultures and enjoy working with others in a collegial and team-orientated manner

• You are flexible, especially because of the fact that assignments cannot always be planned far in advance