Sandoz · Ljubljana (sandoz)Prepare for this interview
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Job Description Summary The future is ours to shape. / Prihodnost je v naših rokah. Job Description With its strategic investments in Slovenia, Sandoz is not just building factories, but shaping the future - for science, for people, and for global healthcare. To realize this vision, we need dedicated, motivated, and passionate professionals who will co-create a success story with their knowledge and commitment. Manufacturing unit Bio Injectable products Brnik will provide advanced pharmaceutical products to patients around the world. We are increasingly focusing on biosimilars, which require exceptional quality of processes and procedures, and above all, high professionalism, dedication and commitment of all employees in the unit. As a C&Q Engineer II (d/f/m) you will be responsible for planning, executing and preparing reports related to the start‑up and qualification of equipment, facilities and processes. This role includes supporting both investment projects in equipment and infrastructure, as well as routine production activities, while ensuring that all procedures are carried out in accordance with established good practices in the pharmaceutical industry. Your responsibilities include, but not limited to: Supporting internal and external assessments , including audits and inspections, as well as sharing and applying best practices in start‑up and qualification activities. Developing, implementing, and maintaining operational and standard procedures , and ensuring appropriate training for employees. Planning and managing project documentation , including timelines, risk assessments, quality plans and proper archiving of project records. Performing technical inspections and equipment tests , such as factory and site acceptance tests, and assessing safety, durability and constructability. Leading change management and handling deviations , including root‑cause analysis and implementation of corrective actions. Collaborating with suppliers and contractors , overseeing their work, coordinating activities, and ensuring compliance with safety and inspection requirements. Planning and supervising maintenance and calibration activities , including task allocation, compliance checks and assessing impacts on equipment quality. Executing qualification activities , from protocol preparation to execution and reporting, including periodic requalification and support during validation. What will you bring to the role: Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent. Minimum 1 year of experience in engineering project / commissioning / qualification / compliance in pharmaceutical industry. Fluent in English and proficient in local language. Knowledge of Microsoft Office.
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