Job
In this role, you independently coordinate CSV projects in regulated environments, create essential life-cycle documents, and monitor compliance with GMP standards and data integrity.
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Job technologies
Your role in the team
- Independent execution and coordination of CSV and qualification projects in a regulated environment involving automated systems.
- Preparation of life cycle documents, such as user requirements specifications, validation plans, risk analyses, and work instructions.
- Assessment, documentation, and follow-up of deviations and CAPAs.
- Ensuring GMP compliance and data integrity as part of CSV.
- Assessment of automation systems from a compliance perspective and ensuring adherence to 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, for example in bioinformatics, computer science, medical technology, biomedical engineering, biotechnology, automation engineering, process engineering, chemical engineering, or a comparable field.
Qualifications
- Enjoyment of customer-focused, quality-conscious, and independent work.
- Strong sense of quality and responsibility.
- Ability to communicate complex technical content clearly and effectively.
- Strong communication skills and ability to work in a team.
- Very good written and spoken German and English skills.
Experience
- At least 2 years of professional experience in CSV, qualification, or validation of IT systems in a regulated environment; candidates from entry level up to senior level are welcome.
- Knowledge of FDA and EU compliance regulations and GAMP guidelines; experience with ERP, MES, LIMS, or SCADA systems is an advantage.
What we offer
- A secure job with varied and challenging responsibilities.
- Room for initiative and the opportunity to contribute your individual strengths.
- A supportive work environment with flat hierarchies and an established first-name culture.
- Flexible working hours with no core hours, as well as the option to work from home.
- VTU Academy with internal and external training opportunities.
- Individual career and development opportunities, both organizationally and through specialist or expert career paths.
- Public transport subsidy of up to €330 per year, preventive care and health initiatives, the option to take a sabbatical of up to 3 months, modern office spaces, employee and team events, and other corporate benefits.
- For candidates with a master’s degree and 2 years of professional experience, the gross monthly salary starts at €4,100 for a full-time position, excluding any all-in compensation; a higher salary may be offered depending on qualifications and experience.
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
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