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

Operations/Project Engineer Qualification in the field of Pharma Engineering Solida # (m/f/d) freelance/in temporary permanent employment for a project Basel Start date: immediately Reference number: 885689/1 Tasks ### • Execution and support of qualification activities in investment projects • Creation and execution of qualification plans and reports • Review of verification documents regarding GMP compliance and fulfillment of acceptance criteria • Creation, tracking, and completion of qualification pending items • Maintenance of inventory data for qualified equipment • Partnership-based cooperation with various interfaces • Presentation of qualification during inspections • Answering inspection questions and maintenance of the contact partner matrix • Estimation and assessment of the impact of changes and deviations on the qualified status and critical aspects • Execution of (re-)qualification measures as a result of changes and deviations • Planning and execution of periodic qualification reviews, approval of technical planning documents, and assumption of inventory responsibility Profile ### • Completed training / studies in one of the disciplines of automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology with sound professional experience in a GMP-regulated working environment • Practical experience in the implementation of technical GMP requirements of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and in operations engineering • Orderly, structured, and exact way of working, high social competence as well as strong teamwork skills • Very good communication and coordination skills, also in dealing with stakeholders at all levels • Openness and ability to actively contribute in a flat and agile organization • Focus on the delivery of results with measurable added value for the business • Quick comprehension as well as the ability to communicate complex matters understandably to customers or authorities • Independent and autonomous processing of complex tasks • Reliable implementation of agreed priorities • Very good German and English skills Benefits ### • Long-term planned project duration in a global top 5 pharma company • Exciting and innovative environment • Appreciative and pleasant working atmosphere