Job
- Level
- Experienced
- Job Field
- BI, Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Rastatt, Hechingen
- Working Model
- Hybrid, Onsite
Job Summary
In this role, you will plan and conduct computer system validations for R&D, production, and quality, create validation documents, and optimize SAP interfaces in accordance with regulatory requirements.
Job Technologies
Your role in the team
- Planning, management, and execution of computer system validations in the areas of R&D, production, laboratory, and quality management.
- Creation, review, and approval of validation documents for computer-based systems (e.g., validation plans, requirements and specifications, IQ/OQ/PQ, risk analyses, deviation reports).
- Creation, review, and implementation of change requests for computer-based systems as well as derivation of necessary validation activities.
- Support in maintaining the master validation plan.
- Consulting departments on the procurement of software and computer-controlled systems.
- Participation in the continuous improvement of internal guidelines and processes for computer system validation.
- Support in auditing suppliers of computer systems.
- Participation as SME in internal and external audits.
- Participation in the validation, support, and further development of SAP systems and their interfaces.
- Analysis, documentation, and optimization of processes in the SAP environment, taking regulatory requirements into account.
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Our expectations of you
Education
- Successfully completed engineering degree in medical engineering, electrical engineering, mechanical engineering, industrial engineering, or a comparable qualification with professional experience.
Qualifications
- Knowledge of the SAP environment (e.g., SAP ERP, SAP S/4HANA) as well as an understanding of SAP interfaces and processes is advantageous.
- Very good analytical skills.
- Technical understanding.
- Communication skills as well as a goal-oriented approach.
- Excellent German and English skills (spoken and written).
Experience
- Initial experience in computer system validation.
- Experience in medical technology or the pharmaceutical industry is desirable.
- Experience with DIN EN ISO 13485, 21 CFR 820, and 21 CFR 11 is desirable.
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What we offer
- Remuneration according to the metal tariff, 30 vacation days per year, and other attractive conditions.
- Flexible, family-friendly working hours and remote work.
- Career opportunities in a renowned company.
- Individual onboarding and opportunities for further training.
- Modern workplace equipment.
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Benefits
Work-Life-Integration
Health, Fitness & Fun
Topics that you deal with on the job
Job Locations
This is your employer
MAQUET Cardiopulmonary GmbH
MAQUET Cardiopulmonary GmbH is a renowned company within the Getinge Group, focusing on the development and distribution of medical products for cardiopulmonary and intensive care. Based in Rastatt, Germany, the company provides solutions for hospitals and clinical applications, particularly in heart-lung support.
Description
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Healthcare, Social Sector
Computer Systems Validation Engineer - Focus on SAP interfaces
- Location
- Rastatt, Hechingen
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
