Plant Engineer Qualification 80-100%

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.

 

At SKAN, healthy growth is important to us. We are always looking for talented individuals to fill a wide range of roles. Apply now!

 

 

Overview

 

We are looking for an experienced person with knowledge of equipment qualification and CSV in the GxP pharma environment to set up our new "Aseptic Manufacturing Services" division. In this role, you will be responsible for the implementation and realization of the qualification strategy for our process equipment. You will also be responsible for supporting and coordinating FATs and preparing the necessary qualification documentation. You can expect a dynamic and committed team of 12 people. In this role, you will make a decisive contribution to the realization of our projects.

 

 

Responsibilities

 

  • Responsible for the development and implementation of new qualification strategies and methods
  • Ensuring and maintaining the qualified status of assigned areas and equipment
  • Aligning qualification strategies with customers to build business needs
  • Responsible for the planning and implementation of qualification measures in accordance with the applicable regulations (cGMP) incl. supervision of FATs
  • Responsible for the planning and execution of preventive maintenance incl. support in the creation of maintenance plans
  • Implementation of optimizations and improvements in the area of responsibility

 

 

Hardskills

 

  • Completed studies in a specialist field (pharmaceutical, process, electrical engineering, biology, mechanical engineering or chemistry)
  • Experience in a GMP environment (ideally in qualification, sterile, ATMP production or CSV)
  • Solid MS Office skills and knowledge of Kneat an advantage
  • Business fluent in German and English

 

 

Softskills

 

  • Enjoy working in a team
  • Solution-oriented thinking
  • High quality standards
  • Open communication
  • Competent appearance towards customers and stakeholders 
  • Precise, structured and reliable way of working

 

 

We offer you

 

  • An open and collegial corporate culture 
  • Room for ideas  
  • Support through further training, especially at our SKAN Academy
  • Intensive and job-orientated induction training
  • Short decision-making processes and flat hierarchies
  • Open communication policy
  • 5 weeks holiday and the possibility of additional days off

 

For questions please contact Ivana Batt.