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Process Validation Engineer

 

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.

 

 

 

Overview

 

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.

 

 

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

 

 

Softskills

 

  • 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 collaborative corporate culture
  • Freedom to contribute and develop ideas
  • Opportunities to participate in sports and social activities
  • Professional development and continuous learning opportunities, especially at our SKAN Academy
  • Comprehensive and career-focused onboarding
  • Quick decision-making paths and flat hierarchies
  • Transparent and open communication
  • 5 weeks of vacation, with the option to take additional leave

 

 

Additional information

 

We look forward to receiving your complete application documents (CV, diplomas and employment references) via our career page.
For this position, we are focusing on direct applications and are not working with external agencies. Any dossiers submitted by agencies will not be processed.

 

For questions please contact Viviane Braxton.

 

Apply now »