StellenbeschreibungFor our client, a global leader in biopharmaceutical manufacturing, we are seeking an experienced MSAT Associate Principal Scientist (m/w/d) General Information Start Date: Duration: 7 months Tasks Responsibilities Define and implement process validation strategies for microbial and biopharmaceutical manufacturing processes in compliance with Validation Master Plans (VMPs), SOPs, and regulatory requirements. Author, review, and maintain process validation documentation, including study designs, protocols, reports, and process validation lifecycle documentation. Develop and maintain Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight and lifecycle management. Support process characterization activities, assess validation data, and collaborate with RD and cross-functional teams to ensure successful execution of validation activities. Coordinate change controls and deviations, support investigations, define corrective actions, and participate in cross-functional risk assessments. Act as the process validation subject matter expert during customer audits, health authority inspections, and validation-related Quality activities. Support validation training initiatives and drive effective collaboration between MSAT, QA Validation, Cleaning Validation, QA Qualification, and other key stakeholders. Your Profile Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or a related Life Sciences discipline. PhD preferred. 5-10 years of experience in biopharmaceutical manufacturing environments. Strong experience in process development, process validation, and MSAT environments. In-depth understanding of Process Validation Lifecycle, Continued Process Verification (CPV), and Product Quality Reviews (PQRs). Solid knowledge of GMP requirements and regulatory expectations for biologics and microbial processes. Experience supporting audits, inspections, deviation management, and change control activities. Business fluency in English; German is advantageous. #J-18808-Ljbffr
