Qualification / Validation Expert - 1 year fixed-term

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionThe Clinical Manufacturing Network (PTDN) produces groundbreaking therapies from clinical phases to supply patients all over the world - and does so every day. Our core business is the production of safe, innovative and effective medicines, using state-of-the-art technologies in manufacturing processes for active ingredients and medicinal products. Within our Science & Technology section, we strive for process technology excellence to ensure highest quality and regulatory compliance in the Drug Product Clinical Supply Center (Parenterals) in Basel. Together, we are responsible for the manufacture and filling of sterile dosage forms from the global research and development portfolio. Future-oriented manufacturing facilities in a modern building are available for the supply of clinical trials in phases I-III.We strive for a caring and empathetic network organization that lives a culture of trust and collaboration. Our dedicated employees drive innovation through their expertise, their passion and their "get-it-done" mentality. In doing so, the benefit to the patient is at the center of our considerations and efforts.The opportunity:Independent and autonomous support of all process technology aspects of plants and equipment for the manufacture and filling of parenterals as a subject matter expert (SME) with internal and external representation of our organizationCreation of concepts and rationales to ensure the qualified or validated status of our manufacturing, cleaning and sterilization processes based on applicable specifications and regulatory requirementsPlanning and implementation of qualifications & validations in the aseptic working environment incl. creation of documentation based on Good Documentation Practices (e.g. development of VPHP decontamination, sterilization validations and cleaning effectiveness)Coordination and execution of process technology changes and optimizations to process plants in cooperation with internal partners (including workshops, automation, engineering and quality assurance) and external service providersOwnership of simple to complex deviation, change and CAPA records incl. root cause analyses as well as participation in Quality Risk Management and in operational SOPs related to the area of responsibilityLeading investigations and troubleshooting for plant problems and participation in process-related deviations in manufacturingRepresentation of the area in local as well as global committees, inspections and audits, as well as active support of complex local and global projectsWho You AreYou are positive, open to new ideas and question conventions. You value a performance-oriented environment with respect and support. You see mistakes as an opportunity for further development. Then Roche offers you an exciting, international working environment with diverse development opportunitiesYour interdisciplinary mindset, intrinsic motivation and ability to integrate characterize you. Continuous improvement and highest quality are your focus. You promote decisions at the lowest level, address controversial topics and act goal-oriented with lean, agile working methods in a teamYou have a completed scientific / technical degree (e.g. pharmaceutical technology, chemistry / pharmacy, process / chemical engineering, biotechnology) or vocational training in the pharmaceutical environment with several years of relevant professional experience and at least 5 years of experience in a GMP-regulated environmentYou have in-depth knowledge of production processes, pharmaceutical or process engineering with technical understanding and interest in complex, highly automated plants as well as knowledge in handling Quality RecordsYou are responsible for the short- and medium-term resource planning of your own capacity in connection with transparent task prioritization.You have good knowledge of leading GMP regulations (including EMA, FDA and PIC/S Guidelines)You have a strong sense of responsibility, an exact way of working and reliability even under time pressure as well as strong communication skills, teamwork and a high degree of flexibility and initiativeYou can confidently use standard office programs as well as production-supporting IT systems (e.g. Veeva, eVAL, SAP, MES, Learning Management System)You have business fluent German and English skills in speaking and writingYou have on-call readiness for technical malfunctions as neededAre You ready for Your application?  Who we areA healthier future drives us to innovate. Together, more than 100-000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let-s build a healthier future, together.Roche is an Equal Opportunity Employer.