Qualification Engineer in the field of temperature-controlled facilities/rooms

Qualification Engineer in the field of temperature-controlled facilities/rooms ----------------------------------------------------------------------------- Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our long-standing customer, F. Hoffmann - La Roche AG in Basel, we are looking for a Qualification Engineer in the field of temperature-controlled facilities/rooms ================================================================================= Background: The Infra Qualification department is looking for suitable candidates with experience in plant qualification, experience in creating work instructions and process descriptions, as well as GMP consulting for internal clients. The work environment includes the care of temperature-controlled facilities/rooms. Tasks & Responsibilities: • Creation of qualification documents and execution of qualifications according to the Roche quality system • Evaluation of technical changes to facilities with regard to their impact on the qualified state and independent processing of requalification activities • GMP-compliant documentation of the work carried out and summary of the deviations that occurred • Conducting qualification reviews • Development of solution proposals for the deviations that occurred • Introduction to electronic qualification and validation software (ELVIS) • Support in the creation of work instructions • Participation in inspections and audits • Possibly taking on supporting functions in the SPOC area (e.g. inventory maintenance, SOPs, SPOC representation) Must Haves: • Completed training/studies in one of the fields: automation, mechanical engineering, process engineering, pharmaceutical technology or biotechnology • At least 3 years of professional experience with qualifications in the plant environment • CSV knowledge desirable • In-depth professional experience in a GMP-regulated work environment • Very good German language skills in word and writing, as well as good English language skills • Good IT skills (e.g. Google software package, MS Office) What we offer: • The opportunity to work for one of the most important pharmaceutical companies in the world • Modern campus with a lot of green spaces and meeting zones • Varied activity profile • Further training opportunities through temptraining • Working in a dynamic and motivated team You are welcome to send your complete application documents to Frau Diana Afonso. Basel Basel-Land Aargau Chemistry Pharma GMP Qualification ELVIS CSV SPOC SOP