Overview In this CSV Engineer role, you validate and validate-compute systems on process equipment and MES, guiding CSV activities across plant life cycles. You work on-site to ensure precise, compliant validation and drive ongoing process improvements. You collaborate closely with QA and cross-functional teams to meet high standards for medicines manufacturing. You will manage commissioning, validation documentation, and alignment with regulatory expectations. This opportunity offers an agile culture, relocation support, and a clear path to impact in a global life sciences company. Leistungen / Benefits Relocation assistance for eligible candidates and families Competitive salary Lifestyle, family and leisure benefits Agile career and dynamic working culture Inclusive and ethical workplace On-site role for close collaboration Verantwortungsbereiche Prepare commissioning and validation documents for new systems and supervise conversions, expansions, or new builds Oversee deviations, changes (GEP and GMP) and CAPAs to ensure protocol adherence Coordinate CSV activities with internal groups and external providers for seamless integration Present CSV documents during audits and inspections to uphold high standards Schedule and report CSV activities to maintain flawless progress records Align CSV strategy with QA CSV for Biologics scope Contribute to review and continual improvement of CSV documents for ongoing success Zentrale Anforderungen Significant experience in a regulated environment with respect to CSV Solid educational foundation in a technical field Good knowledge of Microsoft Office and Delta-V Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP is an advantage Proficient in English; German skills are advantageous cross-functional collaboration attention to detail proactive problem solving CSV in regulated environments Delta-V KNEAT
CSV Engineer Biologics 80-100% (m/f/d) Arbeitgeber: Lonza
Lonza ist ein hervorragender Arbeitgeber, der eine dynamische Arbeitskultur und flexible Arbeitsmöglichkeiten bietet, um die besten Talente zu fördern. Mit einem starken Fokus auf persönliche Entwicklung und Teamarbeit ermöglicht Lonza seinen Mitarbeitern, ihre Karriere in einem bedeutenden Bereich wie der internen Revision voranzutreiben, während sie gleichzeitig zur Verbesserung von Millionen von Leben beitragen. Die enge Zusammenarbeit vor Ort fördert nicht nur den Austausch von Ideen, sondern auch die technische Präzision, die für die Herstellung von Arzneimitteln erforderlich ist.
