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 organisation have made SKAN a market leader and a key partner to industry and research laboratories.
Process Validation Engineer
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‑oriented 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‑oriented manner
You are flexible, especially because 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
For questions please contact Viviane Braxton.
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