Validation Consultant

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. To provide cleaning validation support at the direction of Validation Manager which may include but not limited to: Assessment and development of the cleaning processes (during New Product/Process/Equipment Introduction) New and/or ongoing Cleaning Process Qualification (i.e., cleaning validation protocol/report generation & execution) Continued Process Verification (i.e., periodic reviews, re-validation/re-qualification of the changed cleaning processes) Non-confirmatory event resolutions / cleaning process discrepancy handling Conducting other design of experiments / studies in support to robust cleaning process Consultant will be on site following all Rentschler Policies and SOPs All documentation created by consultant will be reviewed and approved by SMEs (Validation, Engineering, QC; QA as applicable) Rentschler Biopharma is a 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. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. 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, we pursue one vision together: advancing medicine to save lives. If you are having difficulty applying, get in touch with our recruiting team: welcome@rentschler-biopharma.com