Computational Systems Validation Engineer CSV (x|w|m) – Hybrid

Be prepared and filled with life for our new, modern location for commissioning and qualification. We are looking for a CSV Engineer (x|w|m) – Hybrid, On-site at the location Freiburg, Sartorius CellGenix GmbH. In this role you are responsible for creating and implementing the validation of computer-assisted systems to process equipment and facilities. In addition, you take over the planning and implementation of CSV activities and contribute to the continuous optimization of processes, plants and internal processes.

The job is full-time and takes place daily remotely and locally at our location in Freiburg, our competence center for the development and production of biotechnological cell culture components.

They plan, coordinate and conduct validation projects for computer-assisted systems according to regulatory requirements (e.g. GxP, 21 CFR Part 11, EU-GMP, GAMPx).

You create, review and release validation documents, including validation plans, risk analyses, test plans, protocols and reports

They monitor deviations, changes and CAPAs and ensure compliance with internal policies and regulations

They carry out risk analyses and software tests (IQ, OQ, PQ) as well as function, integration and regression tests.

They support the implementation of new IT/OT systems or updates of existing systems, taking into account the validation requirements.

They work with interdisciplinary teams to ensure the efficient and regulatory function of the systems

They are responsible for the submission of CSV documents in audits and inspections, as well as support staff in relation to computer-assisted systems and their validation

They have a master's degree in computer science, engineering, bioprocess engineering or a comparable discipline

They first experience in the validation of computer-assisted systems in regulated environments of the pharmaceutical, biotech or medical device industry

You have knowledge of relevant regulations and standards (e.g. GxP, 21 CFR Part 11, Annex 11, ISO 13485, GAMPx)

They are familiar with quality assurance systems (QMS) and their integration into the IT/OT infrastructure

You are fluent in German and very good English

You are familiar with technical programs

They are characterized by strong communication and team skills and can work effectively in an interdisciplinary environment

They have strong analytical thinking and problem-solving capabilities, combined with a proactive and independent working method

They identify with our corporate values: sustainability, openness and joy

As a globally growing life science company listed in the DAX and TecDAX, Sartorius offers a variety of advantages: Life Science & World Health: Social added value through passion for shaping the future of tomorrow

Open corporate culture: characterized by diversity, team spirit and progress

Personal development offers: training, coaching, leadership programs, etc. at global level

Successful company on growth course: permanent employment contract, 30 days per year and a 40h week inclusive flexible working time with sliding time and contribution to the occupational retirement provision

Well-Being: Free drinks (coffee, tea and water) as well as attractive corporate fitness offers

Mobility benefits: Good access to public transport and free parking

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