CSV / System-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 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

For the development of the new business unit “Aseptic Manufacturing Services” we are looking for an experienced CSV / System Engineer with knowledge in the GxP pharma environment. This position is responsible for the validation of computerized systems and the implementation of own projects in the area of vertical and horizontal integration. You can expect a dynamic and committed team and this role is an important factor for the realization of our project and area.

Responsibilities

• Responsibility for the validation of computerized systems for manufacturing and laboratory equipment
• Support in the implementation of projects in the area of vertical and horizontal integration, including the various interfaces (technical and organizational)
• Evaluation of systems to ensure compliance and adherence to applicable standards (e.g. GAMP 5)
• Support and responsible for the maintenance and technical availability of the systems
• Creation of concepts for the management and transfer of production and laboratory data incl. CSV documents, risk analyses, data structure
• Contact person for efficient troubleshooting in the entire system landscape
• Support with inspections by the authorities
• Processing change requests and deviation reports

Hardskills

• Bachelor's degree from a university of applied sciences or technical college (HF) in the field of automation or computer engineering
• Experience and in-depth knowledge of the GMP environment (ideally in the operation or validation of computer systems, applications and networks/communication technology)
• Experience in project management
• Solid knowledge of SAP and MS Office
• Experience with MES systems (e.g. Lonza Moda), Historian (e.g. Aveva PI) or Scada systems (e.g. Copa - data Zenon)
• Business fluent in German and English

Softskills

• Solution-oriented and structured thinking
• High quality standards
• Open communication
• Competent and professional appearance towards customers and authorities
• Precise and careful way of working

We offer you

• An open and collegial corporate culture
• Entrepreneurial freedom
• 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.