Qualification Engineer - Ultra-Pure Media

ppFor one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a /p pbQualification Engineer in the field of Ultra-Pure Media (Reinstmedien). /b /p h3General Information: /h3 ul libStart Date: /bideally ASAP /li libDuration: /b1 year with likely extension /li libWork Location: /b Basel and Kaiseraugst /li libHome Office: /bpossible after onboarding (frequent onsite presence is preferred) /li libTravel: /b occasional, for FAT activities /li libDepartment: /bTechnical Compliance /li libWorking Hours: /b Standard /li /ul h3About the Job: /h3 pAs a Qualification Expert, you will work in the "Infra Qualification" Circle at our Basel/Kaiseraugst location which creates and maintains the GxP-qualified status of facilities, equipment and systems in the areas of "Infra Logistics, QC Labs." /p pThe SPOC (Single Point of Contact) area of Infra Energy Operations manages facilities and /p psystems for the generation and site-wide distribution of GMP media (purified water, nitrogen, /p pand processed air). /p pYou will be responsible for creating qualification documentation in accordance with all internal /p pand regulatory requirements and maintaining it according to our established processes. You will /p pcontribute your expertise to clarify and present technical GMP topics in a sustainable manner. /p pYour daily tasks will also include interdisciplinary collaboration with our internal client groups. /p h3Tasks Responsibilities: /h3 ul liCreating qualification documents and conducting qualifications according to the Quality System /li liAssessing technical changes to equipment regarding their impact on the qualified status and independently handling requalification activities /li liGMP-compliant documentation of the work performed and summarizing the deviations encountered /li liDeveloping solutions to identified deviations /li liFamiliarization with electronic qualification and validation software (ELVIS) /li liSupporting the creation of work instructions /li liParticipating in inspections and audits /li liPossibly assuming support functions in the SPOC area (e.g., inventory management, SOPs, SPOC representation) /li /ul h3Must Haves: /h3 ul liCompleted vocational training/degree in one of the following fields: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, or Biotechnology /li libMinimum 3 years of professional experience with qualifications in the plant engineering sector /b /li liExperience with bUltra-Pure Media (Reinstmedien) /b /li liExtensive professional experience in a bGMP-regulated work environment /b /li liExcellent written and spoken bGerman and English skills /b /li /ul h3Nice to Have: /h3 ul liCSV knowledge /li /ul /p #J-18808-Ljbffr