Job
- Level
- Experienced
- Job Field
- IT, BI, System
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Salary
- 3.770 to 4.700€ Gross/Month
- Location
- Linz, Vienna
- Working Model
- Hybrid, Onsite
Job Summary
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.
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.
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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.
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Benefits
More net
Work-Life-Integration
Health, Fitness & Fun
Food & Drink
Topics that you deal with on the job
Job Locations
This is your employer
VTU Engineering
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.
Description
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Engineering Industry
Project Engineer Computer System Validation
- Salary
- 3.770 to 4.700€ Gross/Month
- Location
- Linz, Vienna
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
