Operations/Project Engineer Qualification in the field of Pharma Engineering Solida

Operations/Project Engineer Qualification in the field of Pharma Engineering Solida ------------------------------------------------------------------------------ Roche Switzerland bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our long-standing client, F. Hoffmann - La Roche AG in Basel, we are looking for a Operations/Project Engineer Qualification in the field of Pharma Engineering Solida ================================================================================== Background: The Department Drug Product Qualification is looking for an expert in the field of qualification for independent operations engineering activities or project work in the area of Drug Product Basel and Kaiseraugst. Tasks & Responsibilities: • Execution and support of qualification activities in investment projects • Creation and execution of qualification plans and reports • Checking of verification documents for GMP compliance and fulfillment of acceptance criteria • Creating, tracking, and closing qualification pending items • Maintaining the inventory data of the qualified equipment • Partnership-based collaboration with interfaces • Presenting the qualification during inspections, answering inspection questions, maintaining the contact partner matrix • Estimating and assessing the impact of Changes and Deviations on the qualified status and Critical Aspects • Executing (re-)qualification measures from Changes and Deviations • Planning and conducting periodic qualification reviews • Releasing technical planning documents • Taking on inventory responsibility Must Haves: • Completed training/studies in one of the following disciplines: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology, Biotechnology • Min. 5 years of professional experience in qualifications of automated pharma production (Drug Product) (**) • Professional experience in a GMP regulated working environment • Orderly, structured, and exact way of working • High social competence, teamwork skills, and very good communication and coordination skills, including interaction with stakeholders at all levels • Openness and ability to actively contribute in a flat, agile organization • Practical experience in the implementation of technical GMP requirements of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and operations engineering • Focus on delivering results that make a valuable contribution to the business • Quick comprehension as well as the ability to break down complex issues and communicate them to customers or authorities in appropriate language • Independent and autonomous processing of complex tasks as well as reliable enforcement of agreed priorities • Very good German language skills and English language skills are required What is offered to you: • A chance to contribute to one of the most significant pharmaceutical companies in the world • Modern campus with many green spaces and meeting zones • Varied activity profile • Further training opportunities through temptraining • Collaboration in a dynamic and motivated team You are welcome to send your complete application documents to Ms. Diana Afonso. Basel Basel-Land Aargau Chemie Pharma GMP Solida Ingenieur Change Deviations Verfahrenstechnik Pharmatechnik