Qualification Engineer (m/w/d)

Seniority Level Employee Professional category Industry & Production Job percentage 80 - 100 % Job type Temporary Reference number AFE-IP-T-54233 Description ### As a First-Tier-Supplier of our renowned business partner, F. Hoffmann-La Roche Ltd. in Basel and Kaiseraugst, we are immediately seeking a motivated and dedicated Qualification Engineer in the field of temperature-controlled systems/rooms for a temporary deployment of 1 year, with the option of extension. The Infra Qualification team 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 ideal 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. Furthermore, very good German language skills in writing and speaking as well as good English language skills are required. Tasks & Responsibilities ### • Creation of qualification documents and execution of qualifications according to the Roche quality system • Evaluation of technical changes to systems 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 • Carrying out 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 • 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 fields: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology or Biotechnology • At least 3 years of professional experience with qualifications in the plant environment • 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) Nice-to-Haves ### • CSV knowledge desirable Benefits ### • Become part of one of the most renowned pharmaceutical companies and actively shape the future of healthcare • Experience a corporate culture that promotes diversity and inclusion and in which all employees feel valued • Work on a state-of-the-art campus with green spaces, meeting zones and an inspiring atmosphere • Work with modern and current tools in an innovative work environment • Start with professional onboarding and a thorough introduction to your new role during the Welcome Days • Benefit from financial support for your professional further training plans • Enjoy a selection of high-quality food in modern company restaurants • Take advantage of attractive fitness and swimming pool offers or the gaming room as a creative retreat • As part of a sustainable mobility concept, you will have parking facilities on site (according to internal guidelines) • Take advantage of unbeatable, year-round discounts from well-known retailers and over 200 top brands • Benefit from fleet discounts when buying new cars or receive ongoing discounts on fuel with our fuel card Are you interested? Don't hesitate and submit your complete application documents online today. We look forward to you!