Operations/Project Engineer Qualification in the field of Pharma Engineering Solida (m/f/d)

Seniority Level Employee Job Category Electrical & Mechanical Percentage 100 % Job Type Temporary Reference No. AFE-EM-T-54528 Description ### For our renowned business partner, F. Hoffmann-La Roche in Basel/ Kaiseraugst, we are looking as a first-tier supplier, effective immediately, for a motivated and committed Operations/Project Engineer Qualification in the field of Pharma Engineering Solida for a fixed-term assignment of 12 months with the possibility of extension. Tasks & Responsibilities ### • Implementation and support of qualification activities in investment projects. • Creation and execution of qualification plans and reports • Checking verification documents for GMP compliance and fulfillment of acceptance criteria • Creating, tracking, and closing qualification pending items • Maintaining the inventory data of the qualified plants • Collaborative cooperation 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 performing periodic qualification reviews • Releasing technical planning documents • Taking on inventory responsibility Must Haves ### • Completed training/studies in one of the following 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, including 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 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 ability to break down complex facts and communicate them in appropriate language to customers or authorities • Independent and self-reliant processing of complex tasks as well as reliable enforcement of agreed priorities • Very good German skills and English skills are required Have we aroused your interest? Do not hesitate and submit your complete application documents to us online today. We look forward to seeing you!