Qualification Engineer

Qualification Engineer Qualification Engineer: Qualifications / Validation software / CSV / Automation / Process engineering / Pharmaceutical technology / Biotechnology / Plants / GMP / German / English / Project: For our client, a large pharmaceutical company based in Basel, we are looking for a Qualification Engineer in the field of temperature-controlled systems / 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 maintenance of temperature-controlled systems / rooms. The perfect candidate: has a degree in Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology or Biotechnology. The person has at least three years of professional experience in plant qualification and in-depth knowledge of the GMP-regulated work environment. CSV knowledge is desirable. Additionally, very good German language skills in writing and speaking as well as good English language skills are required. Tasks & Responsibilities: Create qualification documents and conduct qualifications according to Roche Quality System Evaluate technical changes to systems with regard to their impact on the qualified state and independently work on requalification activities GMP-compliant documentation of the work carried out and summary of the deviations that occurred Conduct qualification reviews Develop solution proposals for the deviations that occurred Training in electronic qualification and validation software (ELVIS) Support in creating work instructions Participation in inspections and audits Take 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 3 years of professional experience with qualifications in the plant environment CSV knowledge desirable In-depth professional experience in the GMP-regulated work environment Very good German language skills in writing and speaking, as well as good English language skills Good IT skills (e.g. Google software package, MS Office) Reference No.: 925058 Role: Qualification Engineer Industry: Pharma Workplace: Basel & Kaiseraugst Working hours: 80 - 100% Start: () (Latest possible start date: ) Duration: 12+ Months Application deadline: If this position has sparked your interest, please send us your complete dossier. If this position does not fit your profile so well and you would like 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 more 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, and we also do not charge any additional fees for payroll. jpidba67babjm jit0727jm jiy26jm