Senior Applications and Configurations Manager MES (m/f/d)

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

Tasks and responsibilities Participation in the cross-site introduction and operation of a Manufacturing Execution System (MES) Responsibility for the transformation of paper-based manufacturing regulations into standardized MES system recipes for the cross-site production of biopharmaceuticals Support in and independent creation of system recipes Project management for the MES division rollout including status/transparency reporting, risk management and success control Device integration and interface integration Definition, standardization and maintenance and optimization of workflows, master data and system configurations to MES 1st/2nd Level Application Support for MES Periodic system review Application Change Management incl. MOC processes Validation and testing of developments and configurations including OQ/PQ Monitoring data quality, data integrity, process sequences and system performance System and data evaluations Support and control of external service providers for customizing, operation or integration Representation of the department in inspections, audits and self-inspections Creation, care and further development of GMP-compliant documentation (SOPs, WINs, training materials) Training, training and system instruction on the technical system and on basic processes (cross-site)

This is important to us Complete studies in a relevant field (e.g. engineering, information technology, natural sciences) Very good knowledge of the application of MES as well as experience in configuration and adaptation desirable Knowledge in database management desirable Flexibility and readiness to work into specific tools and technologies of system providers Excellent communication skills Experience in the creation and maintenance of GMP documentation and in the implementation of audits Professional experience in the GMP environment Experience in managing projects Very good MS Office knowledge Very good knowledge of German and English in word and writing Embossed communication and team skills as well as economic and analytical thinking Hands-on mentality, enforcement and organizational skills

You can look forward to this Sensorship: Become part of a company that makes a real difference for seriously ill patients through the development and production of vital medicines Inspiring working atmosphere: Experience the joy of working in a collegial environment that promotes cooperation and team spirit on site Individual development opportunities: access to personalised training programmes Remuneration: Attractive remuneration and 13. Contents Flexible work design: flexible working hours, sliding time account, possibilities for mobile work, 30 holiday days and special holiday days Community breaks: Canteen with vegetarian/ vegan offer Health: Occupational Health Management, Occupational Health Care Joint experiences: team and company events Environmentally friendly mobility: leasing offer for (e-)bikes, e-rollers and e-scooters Family-friendly support: In-house crèche Safe workplace: Future-proof industry with an unlimited contract Employee benefits: variety of employee rebates (Corporate Benefits), benefits in the job ticket, financial support in moving from a certain distance, free parking, comprehensive onboarding program