Qualification Engineer

Qualification Engineer Qualification Engineer (m/f/d) \- GMP / Qualification / Documentation / German / English Project: For our customer, a large pharmaceutical company based in Kaiseraugst, we are looking for a Qualification Engineer (m/f/d) Background: As a qualification expert, you will work in the "Infra Qualification" circle of the Basel / Kaiseraugst location. The "Infra Qualification" circle creates and maintains the GxP-qualified status of plants, equipment and systems in the areas of "Infra & Logistics, QC & Labs". The SPOC area Infra Energy Operations manages plants and systems for the production and site-wide distribution of GMP media (Purified Water, nitrogen and process air). As a qualification expert, you are responsible for creating the qualification documentation in compliance with all internal and regulatory requirements and maintaining it according to our established processes. You will contribute your personal wealth of experience to sustainably clarify and present technical GMP topics. Your daily tasks also include interdisciplinary interaction with our internal customer groups. The perfect candidate: has a completed degree or training in the fields of automation, mechanical engineering, process engineering, pharmaceutical technology or biotechnology. He or she brings at least three years of sound professional experience in plant qualification within a GMP-regulated working environment and also possesses knowledge in GMP consulting as well as ideally in Computer System Validation (CSV). The profile is rounded off by very good German and good English skills as well as confident handling of common IT systems. Main tasks and areas of responsibility: Creation of qualification documents and execution of qualifications according to the Roche quality system Evaluation of technical changes to plants regarding their influence on the qualified state and independent processing of requalification activities GMP-compliant documentation of the work performed and summary of the occurred deviations Execution of qualification reviews Development of solution proposals for the occurred deviations Training in electronic qualification and validation software (ELVIS) Support in the creation of work instructions Participation in inspections and audits Assumption of supporting functions in the SPOC area (e.g. inventory maintenance, SOPs, SPOC representation) Must Haves: Completed training / studies in one of the following fields: Automation, mechanical engineering, process engineering, pharmaceutical technology or biotechnology 3 years of professional experience with qualifications in a plant environment In-depth 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) Reference No.: 925043 Role: Qualification Engineer Industry: Pharma Work location: Kaiseraugst Workload: 80-100% Start: Duration: 12++ Application deadline: If this position has piqued your interest, please send us your complete dossier. If this position does not fit your profile so well and you wish to receive other positions directly, you can also send us your dossier via this advertisement or to jobs\[at\]itcag\[dot\]com. Contact us for further information about our company, our positions or our attractive Payroll-Only program: . About us: ITech Consult is an ISO 9001:2015 certified company with branches in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for personnel leasing in the areas of IT, Life Science & Engineering. We offer personnel leasing & payroll services. For our candidates, this is free of charge; even for payroll, we do not charge you any additional fees. jpid57d4bc8jm jit0729jm jiy26jm