Senior CSV Engineer - Automation, IT/OT & Computerized System Validation (m/f/d)

As a CSV Process Engineer (m/w/d), you are particularly responsible for: Planning and design of automated systems and complex IT/OT infrastructures Planning data centers and technical network structures Creation and evaluation of network topology plans and information structure models Creation of measurement point, alarm, parameter, data point and identification lists Creation and testing of functional specifications and other technical documentation Implementation and coordination of computerised system validation activities for GLT, monitoring, track-&-trace, MES, ERP and LIMS systems Implementation of CSV tests also in complex IT/OT environments Evaluation and testing of data transmissions via different interfaces Testing of program code and tuning of technical requirements as well as step chains with programmers Coordination and technical support of automation and network technicians as well as other project partners Leading negotiations in the field of automation and network technology Implementation and support of the validation of complex automated systems and network systems Support for GMP-compliant planning, documentation and implementation of computer-assisted systems The special thing: you combine planning, technology and validation. This allows you to have a direct influence on how modern digital and automated systems are used safely, efficiently and in a regular manner in the pharmaceutical industry.

You are delighted to solve complex technical issues, take responsibility and develop resilient solutions together with customers and project teams. Ideally you bring: Complete studies in the field of automation technology, electrical engineering, computer science, process engineering, pharmaceutical technology or a comparable field of expertise Experience in computerised system validation and/or in the planning of automated systems Knowledge of how to use IT networks and how to build and structure control cabinets Experience with GLT, Monitoring, Track-&-Trace, MES, ERP and LIMS systems Knowledge of data transmission via different technical interfaces Good knowledge of GMP regulations, in particular EU-GMP Annex 11 and Annex 22, as well as relevant Aide-Memoire provisions Knowledge in the field of critical infrastructures, in particular NIS1/NIS2, HV benchmark catalog and IT-Grundschutz-Kompendium Experience in creating network topology plans and information structure models Knowledge in the creation of measurement points, alarm, parameter, data point and identification lists as well as functional specifications Experience in performing CSV tests in complex IT/OT infrastructures Ability to check program code and to convey technical step chains understandably to programmers Structured, independent and solution-oriented mode of operation Embossed hand-on mentality and joy in actively addressing technical challenges Communication strength and safe occurrence to customers, suppliers and project partners very good knowledge of German and English, willingness to project-related travel as well as a driving licence of class B.

At Process [.-ING] you will not only expect exciting projects, but also an environment in which you can actively shape your professional and personal development: Responsibility and design space You take independent responsibility in demanding pharmaceutical and biotech projects and actively shape technical solutions. Technical development We offer you attractive professional and personal training and development opportunities – with a perspective on a function as a leading engineer. Demanding projects Different customers, technologies and project phases ensure the professional width and new challenges instead of daily routine. Security and perspective You work in an established, owner-managed engineering and consulting company with a long-term perspective. Flexibility Flexible working hours and the possibility of hybrid work support a project-oriented design of everyday work. Attractive remuneration We offer a fair remuneration and participation in our bonus program. Health and coexistence A collegial working environment with short decision-making paths as well as our operational health management including Wellpass complete our offer. Why Process [.-ING]? At Process [.-ING], around 300 employees work to develop and implement technical solutions for the pharmaceutical and biotechnology industry. You meet our technical depth, practical engineering work and demanding project responsibility – combined with the development possibilities and short decision-making paths of an owner-managed company. If you want to introduce your experience and take the next step in your professional development, we look forward to meeting you. Design the pharmaceutical factory of the future with us. .