CSV Engineer Emploi Plein temps
il y a 8 mois - Engineering - AllschwilDétails de l'annonce
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!
Responsibilities
- Co-design of the test procedure according to 21 CFR Part 11 and GAMP5
- Co-design of the internal processes as well as those of the related departments
- Coordination of quality-relevant relationships with the internal automation departments (deviations, CAPA, changes)
- Creation of specifications for the simulation/validation components (e.g. for the WinMOD macros, certificate FDA 21 CFR Part 11 Compliance)
- Creation and maintenance of instructions in the area of validation of the automation software
- Carrying out software module tests and reviews
- Administration and maintenance of the validation documents (e.g. SIT FT)
- Support in the creation of the WinMOD applications and the test stations or similar virtualised system with behaviour simulation
Hardskills
- Engineer FH, HF with specialisation in electrical engineering or automation
- Several years of professional experience in plant engineering, preferably with a pharmaceutical background
- Experience in control engineering
- PLC programming knowledge, preferably of Siemens (Step 7/TIA) and/or Allen Bradley controllers
- Confident handling of MS-Office and EDP systems
- German and good technical English skills
Softskills
- Precise and careful way of working
- Coordination skills, ability to work under pressure and in a team
- High level of personal responsibility
- Competent and professional appearance
- Willingness to travel worldwide approx. 10% of the time
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 Désirée Gallicchio