Job
- Level
- Experienced
- Job Field
- IT, System, Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Darmstadt
- Working Model
- Hybrid, Onsite
Job Summary
In this role, you will plan and coordinate Computer System Validation per ISO standards, creating and maintaining all necessary documents. You will assist in qualification and testing activities while closely collaborating with Quality Management.
Job Technologies
Your role in the team
- R-Biopharm offers more than just a workplace. With fascination and joy, we are shaping the transition into a responsible health era. We are a family-owned company with around 1,400 employees and one of Germany's leading biotechnology companies. With excellent technologies, products, and solutions, we ensure the health of patients and consumers worldwide. Become part of our IT team and help us create a better tomorrow today.
- Planning, coordination, and execution of computer system validation in accordance with applicable regulations (ISO 13485:2016, MDSAP, IVDR).
- Creation and maintenance of CSV documents such as validation plans, risk analyses, test concepts, test reports, and SOPs.
- Support in the execution of qualification and testing activities (IQ/OQ/PQ).
- Close collaboration with quality management and the specialist departments.
- Support for audits and inspections in the field of computer-based systems.
- Assessment and implementation of changes within the scope of the Change Control Process.
- Support in the further development of the validation strategy and the standardization of internal processes.
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Our expectations of you
Education
- Successfully completed training in the STEM field or a comparable qualification.
Qualifications
- Enjoyment of working in interdisciplinary teams.
- Knowledge of relevant guidelines and standards (ISO 13485:2016, MDSAP, IVDR, GAMP 5, Annex 11, Part 11).
- Excellent knowledge in the field of documentation.
- Proficient in MS Office and visual process mapping tools.
- Excellent German and English language skills, both written and spoken.
- Analytical and self-reliant action, communication skills, and team ability are required.
Experience
- Initial experience in the field of CSV or quality-regulated work (e.g., according to ISO 9001, ISO 13485:2016).
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What we offer
- Secure job in an independent family business.
- Work-Life Balance: Remote work, flexible working hours, additional vacation days.
- Attractive salary package including Christmas and holiday bonuses.
- Long-term account to enable a sabbatical.
- Extensive training and development opportunities.
- Company pension scheme with an attractive employer subsidy.
- Health and sports offerings such as on-site massage.
- Fresh bowls, Veggie Day, Scrambled Egg Wednesday – all of this is available in our in-house canteen, where fresh, seasonal, and organic-quality dishes are cooked daily.
- Additional extras: Job Ticket Premium, company bike, kindergarten subsidy, corporate benefits, Employee Assistance Program, and much more.
- Attractive location in Darmstadt, ideal connection to the A5, ample employee parking spaces as well as charging stations for electric vehicles.
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Benefits
Work-Life-Integration
Topics that you deal with on the job
Job Locations
This is your employer
R-Biopharm AG
R-Biopharm AG, established in 1988, is a leading company in Clinical Diagnostics and Food & Feed Analysis. With a global team of over 1,400 employees, it provides reliable solutions for critical health issues.
Description
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
IT - Computer system validation
- Location
- Darmstadt
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
