CSV Engineer

CSV 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

In order to maintain and continuously improve the quality of the automation software, we are looking for reinforcement for our validation team in Allschwil. The main activity is the further development of the validation process. The key to success in this position is an endeavour to deal with the requirements, good communication and a high degree of independence. The position offers scope to make a difference and take on responsibility. Please note that this role is not responsible for the development of software, but rather guiding our software teams in quality assurance, risk management and compliance.

Responsibilities

• Design of the test procedure in accordance with 21 CFR Part 11 and GAMP5
• Co-design of internal and cross-departmental processes
• Coordination of quality-relevant relationships with the internal automation departments, QA and product management
• Creation of specifications and requirements for the validation of automation software
• Carrying out software module tests and reviews
• Management and maintenance of validation documents (e.g. SIT FT protocols)
• Creation and maintenance of training documents and instructions
• Realisation of training courses

Hardskills

• Completed university degree in engineering or natural sciences or a comparable degree programme
• Several years of professional experience in the pharmaceutical/biotechnological environment (GMP environment) or in plant construction with a focus on the pharmaceutical environment
• Understanding of programming logic
• Confident handling of IT systems
• Business fluent in English and very good knowledge of German

Softskills

• Excellent written and verbal communication skills
• High level of personal responsibility and independence
• Analytical approach to tasks
• Ability to coordinate
• Competent and professional appearance

We offer you

• An open and collegial corporate culture
• Freedom for ideas
• Participation in sports and leisure activities
• Promotion through further training, especially at our SKAN Academy
• Intensive and job-oriented introduction
• Short decision-making paths and flat hierarchies
• Open communication policy
• 5 weeks holidays and the possibility of further holidays

For questions please contact Ivana Batt