CSV Engineer - ContractLocation: SwitzerlandContract Length: 12 Months
BioTalent are assisting a large Pharmaceutical client in Switzerland source a CSV Engineer to join them on a minimum 6 month contract position.Please note that this role requires you to be fluent in English and German.
The position holder is responsible and accountable for the development, execution and qualification/validation of computerized System. Support of CapEx-Projects in all phases. Coordination of Supplier for Software development for Clean Utilities (CUA) including Utilities.Responsibilities
- Responsible and accountable for the technical management of approved CapEx-projects for computerized Systems for the Clean Utility Automation and enable the start up, the commissioning and the validation of the CUA-System.
- Coordinate with others engineers (ex. MES, PCS,BMS,FMS) in the project in order to assure overall coordination of the requirements and documentation.
- Liaises with customer groups on the project to ensure delivery according to user requirements, in accordance with quality and safety requirements.
- Develops the CUA System Interfaces and delivers according to the project schedule and requirements as well as the needs of the future established organization.
- Provide the necessary support and management for multi-site projects to deliver automation expertise for the company's key projects.
- Support the Lead CUA System Group in the setting up of the of the new Quality management system, including SOPs for qualification and requirement for computerized system's for CUA
- Support of the Maintenance Groups in the definition of the maintenance system and to improve the know how to support and maintain computerized systems
- Responsible and accountable for work according to cGxP, health, safety and environmental requirements as laid out in the SOPs and procedures as well as all relevant external / governmental guidance.
- Contributing to the delivery of the company strategy as well as supporting the financial CapEx budgeting process.
- Responsible and accountable for all projects (computerized Systems) related documents such as qualification (DQ, IQ, OQ, PQ), User requirements specifications, requirement specifications etc. dealing with the BMS-System.
- Degree (bachelor, master or long experience in an equivalent position) automation-, electro- or electronic- engineer, Dipl. Ing. or M.Sc. or B.Sc. or equivalent.
- Years of successful project execution and experience on mid-sized and major projects for computerized systems with high complexity and multiple interfaces (CUA, MES, PLS) in the chemical, biotech-or pharmaceutical industry.
- Proven project execution skills including document development and software implementation
- Proven experiences and knowledge in automation systems, Networks and PLC technology.
- Proven customer focus experiences and situation al adaptability with both internal and external resources.
- Proven experience in cGxP, qualification
- Proven experience in support of multi-site projects
- Languages: German and English fluent in written and spoken
If you are interested in this position then please apply within, or email me on firstname.lastname@example.org with an up to date copy of your CV.