Process Validation Engineer - Microbiology

About the role

SKAN, a pioneer in cleanroom equipment and isolators for the pharmaceutical industry since 1968, is looking for a Process Validation Engineer for its Process Validation Microbiology (PVM) department. The team develops and validates decontamination processes (H2O2 and E-Beam) for pharmaceutical isolators used in aseptic manufacturing of sterile drugs. The role involves up to 50% international travel to support customers worldwide.

Key responsibilities

• Develop, validate and implement decontamination processes
• Create test protocols and test reports
• Enable safe and efficient, customer-oriented decontamination processes
• Optimise and requalify existing processes, and provide customer-oriented troubleshooting and consulting
• Carry out internal and external training for customers
• Support cross-functional technological improvements and innovations
• Help maintain, update and improve internal SOPs, documentation and workflows

Required profile

• Bachelor's or Master's degree in life sciences, engineering or technology
• Very good knowledge of English; another foreign language is a plus
• Professional, reliable approach to customer contact and personal responsibility
• Comfortable working across cultures, in a team and in a collegial way
• Flexible, as assignments are not always planned far in advance

Required skills

• Experience in sterilisation technologies (steam, irradiation or ETO) and/or isolator decontamination (H2O2 and/or e-beam) is very welcome
• Cleanroom qualification experience in the medical device and/or pharmaceutical industry is appreciated
• Process validation experience (IQ/OQ/PQ) is an advantage
• Ability to work carefully in compliance with GMP

What we offer

• An open, collaborative corporate culture and freedom to contribute ideas
• Sports and social activities, and professional development through the SKAN Academy
• Comprehensive onboarding, quick decision-making paths and flat hierarchies
• 5 weeks of vacation, with the option of additional leave

Applications are accepted directly through the company's career page (CV, diplomas and employment references); agencies are not involved. Questions can be directed to the named contact person.