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 System / Application Engineer with knowledge in the GxP pharma environment. This role is responsible for setting up, commissioning, qualifying and ensuring the technical / operational availability of OT (Operation Technology) and automation systems. You can expect a dynamic and committed team and this role is an important factor for the realisation of our project and area.
Responsibilities
Realisation of projects in the area of vertical and horizontal integration including the interfaces between OT / IT systems incl. their qualification and validation (CSV = Computer System Validation)
Ensuring and responsible for the implementation of maintenance and technical availability of the systems, taking into account patch management and backup concept in the cGmP environment
Creating reports to analyse production data and electronic batch records in MES
Creation of concepts for the management and transfer of production data
Contact person for efficient troubleshooting in the entire system landscape (hardware, applications and network)
Support with inspections by the authorities
Processing change requests and deviation reports
Hardskills
Proven professional experience (>5 years) in the field of system, application and automation engineering in the pharmaceutical industry (GmP regulated environment)
University degree (Bachelor/Master) or technical school (HF) in the field of automation, computer engineering, system engineering or electrical and information technology
Experience and in-depth knowledge of the GMP environment (ideally in the operation of computer systems, applications and networks / communication technology)
Solid experience in project management
Knowledge of SAP and MS Office
Experience with production-relevant applications and systems such as 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-orientated and structured thinking
High quality standards
Open communication
Competent and professional appearance towards customers and authorities
Precise and meticulous way of working
Proven experience in communicating with interdisciplinary teams and levels
We offer you
An open and collegial corporate culture
Entrepreneurial freedom of organisation
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
