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
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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
