Qualification Engineer for Pure Media 80-100% (m/f/d)

As a first-tier supplier to our renowned business partner, F. Hoffmann-La Roche Ltd. in Basel and Kaiseraugst, we are immediately seeking a motivated and committed Qualification Engineer for a temporary assignment of 1 year, with the option of extension.

The "Infra Qualification" circle at the Basel / Kaiseraugst site creates and maintains the GxP-qualified status of facilities, equipment, and systems in the areas of "Infra & Logistics, QC & Labs". The SPOC area Infra Energy Operations manages facilities and systems for the generation and site-wide distribution of GMP media (Purified Water, Nitrogen, and Process Air).

Tasks & Responsibilities

• Creation of qualification documents and execution of qualifications according to Roche quality system
• Assessment of technical changes to facilities regarding their impact on the qualified status and independent handling of requalification activities
• GMP-compliant documentation of performed work and summarising any deviations encountered
• Conducting qualification reviews
• Developing solution proposals for encountered deviations
• Familiarisation with electronic qualification and validation software (ELVIS)
• Support in the creation of work instructions
• Participation in inspections and audits
• Possibly taking on supporting functions in the SPOC area (e.g. inventory maintenance, SOPs, SPOC representation)

Must-Haves

• Completed training or degree in one of the disciplines of automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology
• At least 3 years of professional experience with qualifications in a plant environment
• Extensive professional experience in a GMP-regulated working environment
• Very good German language skills in spoken and written form as well as good English skills
• Good IT skills (e.g. Google software suite, MS Office)

Nice-to-Have

• CSV knowledge (Computer System Validation) 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 where 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 up-to-date tools in an innovative working environment
• Start with professional onboarding and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff 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, parking facilities are available on site (according to internal guidelines)
• Use unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive ongoing discounts on fuel with our fuel card

Are you interested? Do not hesitate and submit your complete application documents online today. We look forward to hearing from you!

We value diversity and therefore welcome all applications - regardless of gender, social background, religion, age, and identity. For easier readability and better understanding, we use only one gender form. Of course, all gender forms are equally meant in the respective context.

Contact
Adnan Ferizi

Workplace
Basel

Workload
80 - 100%

Position
Employee

Industry
Industry + Production