Qualification Engineer in the Field of Drug Substance (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 in the Field of Drug Substances for a temporary assignment of 1 year, with the option of extension.

Pharma Engineering is looking for suitable candidates with experience both in equipment qualification in the field of Drug Substance (API manufacturing) as well as in Computer System Validation (CSV).
The work environment includes process equipment, media, energy, air conditioning such as reactors, fermenters, centrifuges, purified water, steam, autoclaves, cleanrooms as well as the associated controls and process control systems (CSV).

Tasks & Responsibilities

• Creating concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creating qualification/validation plans/reports for all phases according to Roche quality system
• Conducting qualifications/validations in all phases according to Roche quality system
• Assessing technical changes to equipment regarding their impact on the qualified state and independently handling requalification activities
• GMP-compliant documentation of the work performed and summarising any deviations encountered
• Developing solutions for the deviations encountered
• Familiarising with electronic qualification and validation software

Must-Haves

• Degree in a natural science/engineering field or relevant professional experience.
• At least 3 years of professional experience and solid experience in the qualification process
• Practical professional experience with qualifications/CSV of various types of equipment/systems and rooms/media
• Several years of experience in the GMP field with in-depth understanding of quality systems and lean implementation of GMP requirements
• Good knowledge of the topic "Data Integrity"
• Very good German language skills in spoken and written form, good English skills

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
• Use 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)
• Take advantage of 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
100%

Position
Employee

Industry
Project Management + Management