Job
In this role, you coordinate the execution of CSV and qualification projects, create life cycle documents, and ensure GMP compliance for automated systems in a regulated environment.
This listing has been machine translated. Show original
Job technologies
Your role in the team
- Independent execution and coordination of CSV and qualification projects in a regulated environment on automated systems.
- Creation of life-cycle documents (e.g., specifications, validation plan, risk analyses, work instructions, etc.).
- Evaluation, documentation, and tracking of deviations as well as CAPAs.
- Ensuring GMP compliance and data integrity within the scope of CSV.
- Assessment of automation systems from a compliance perspective and ensuring adherence to all relevant standards.
- Familiarity with the infrastructure of modern computer systems.
- Coordination of interfaces between different project teams.
Our expectations of you
Education
- Completed technical or scientific education, e.g., (Bio-)Informatics, Medical Engineering, Biomedical Engineering, Biotechnology, Automation Technology, Process Engineering, Chemical Engineering, or similar.
Qualifications
- Enjoyment in customer-oriented, quality-conscious, and independent work.
- Strong sense of quality and responsibility.
- Ability to communicate complex technical content clearly and understandably.
- Strong communication skills and team ability.
- Excellent spoken and written proficiency in German and English.
Experience
- Interest or (initial) experience in the field of CSV / qualification / validation of IT systems in a regulated environment - we are looking for candidates from entry-level to senior level.
- Knowledge of FDA and EU compliance regulations as well as GAMP guidelines; experience with ERP, MES, LIMS, or SCADA systems is advantageous.
Benefits
Higher take-home pay
Work-Life-Integration
Health, fitness & fun
Food & drink
Topics you will work on
Job locations
About your employer
Gleisdorf
We are experts in the planning of process plants for industry, with experience in a variety of projects ranging from plant optimization to large-scale investment planning.
- Established Company
- Onsite, Hybrid
- Engineering Industry
More jobs
These jobs might also interest you
Do you enjoy diving deep into code and want to build a product that truly makes an impact? With us, you work hands-on on an AI platform that combines SaaS and on-premises, exclusively relies on open source, and successfully implements AI on-prem and...
We are one of the leading European manufacturers of innovative biomass heating systems (firewood, wood chips, pellets). Due to the strong demand for our products and the excellent future prospects for "renewable energy," we are expanding our team. ...
Do you think in terms of architectures rather than individual features? Would you like to work with customers as an equal? advise, make technical decisions, and work with modern Customer Engagement, Service, Power Shape platform and AI solutions? Then...