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Process Validation Engineer

• Founded in 1968, is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories
• At SKAN, healthy growth is important to us. We are always looking for talented individuals to fill a wide range of roles. Apply now!
• We are looking for a motivated Process Validation Engineer (PVE) for the Process Validation Microbiology (PVM) department headed by Ciming Li. 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

Responsibilities

• 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

Hardskills

• 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 beacause of the fact that assignments cannot always be planned far in advance

We offer you

• An open and collegial corporate culture
• Freedom for ideas
• Short decision-making paths and flat hierarchies
• Job-oriented introduction and training
• Open communication policy
• Participation in sports and leisure activities
• 5 weeks holidays and the possibility of further holidays
• To apply, please upload your complete application documents (CV, diplomas and references) to our career page. We are currently not working with external service providers or recruitment agencies for this position. For questions please contact Andrea Scheurmann