Qualification Engineer Purified Media

Qualification Engineer Purified Media ---------------------------------------- Roche Schweiz bridges the gap between pharmaceuticals 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 a Qualification Engineer Purified Media ============================================ Background: The "Infra Qualification" circle is responsible for the creation, maintenance, and upkeep of the GxP-qualified status of facilities, equipment, and systems in the areas of "Infrastructure & Logistics" as well as "QC & Labs". The SPOC area Infra Energy Operations manages facilities and systems for the production and site-wide distribution of GMP media such as Purified Water, nitrogen, and process air. In this role, you are responsible for the creation and maintenance of qualification documentation, taking into account all internal as well as regulatory requirements. In doing so, you consistently apply established processes and quality standards and continuously develop them. With your expertise and experience, you will contribute to sustainably clarifying, documenting, and presenting technical GMP-relevant issues in an understandable manner. Your daily tasks also include close interdisciplinary cooperation with internal customers and specialist departments, as well as active support in ensuring GMP-compliant facility and system operation. Tasks & Responsibilities: • Creation of qualification documents and performance of qualifications according to the Roche quality system • Assessment of technical changes to facilities regarding their impact on the qualified state and independent execution of requalification activities • GMP-compliant documentation of the work performed and summary of deviations that have occurred • Performance of qualification reviews • Development of suggested solutions for the deviations that have occurred • Training in electronic qualification and validation software (ELVIS) • Support in the creation of working instructions • Participation in inspections and audits • If necessary, taking on supporting functions in the SPOC area (e.g., inventory maintenance, SOPs, SPOC representation) Must Haves: • Completed training / studies in one of the following disciplines: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology, or Biotechnology • At least 3 years of professional experience with qualifications in the facility environment • Profound professional experience in a GMP-regulated working environment • Very good German skills in speaking and writing, as well as good English skills • Good IT skills (e.g., Google software package, MS Office) Nice to Have: • CSV knowledge desirable What is offered to you: • A chance to contribute to one of the most significant pharmaceutical companies in the world • Modern campus with many 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 Marianne Buser. Basel Basel-Land Aargau Chemie CSV ELVIS Qualifizierung Validierung Verfahrenstechnik Maschinenbau Automation GMP Qualitätssicherung