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

Operations/Project Engineer Qualification in the area 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 an Operations/Project Engineer Qualification in the area of Pharma Engineering Solida Background: The Department Drug Product Qualification is looking for an expert in the area 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 the verification documents for GMP compliance and fulfillment of acceptance criteria Creating, tracking, and closing qualification pending items Maintaining the inventory data of the qualified systems Partnership-based collaboration with interfaces Presenting the qualification during inspections, answering inspection questions, maintaining the contact partner matrix Estimating and evaluating 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 education/studies in one of the specialist fields: 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, also when dealing 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 from 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 convey them in appropriate language to customers or authorities Independent and autonomous processing of complex tasks as well as reliable enforcement of agreed priorities Very good German and English skills are required What is offered to you: A chance to participate in one of the most significant pharmaceutical companies in the world Modern campus with lots of 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 Frau Afonso. Basel Basel-Land Aargau Chemie Pharma GMP Solida Ingenieur Change Deviations Verfahrenstechnik Pharmatechnik jpid783efd7jm jit0729jm jiy26jm