Qualification Engineer in the Drug Substance area (m/f/d)

Seniority Level

Employee

Job Category

Project Management & Management

Job Percentage

100 %

Job Type

Temporary

Reference No.

AFE-PM-T-56200

Description ###

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

Pharma Engineering is looking for suitable candidates with experience in both equipment qualification in the Drug Substance area (API manufacturing) and in the area of Computer System Validation (CSV).

The working environment includes process plants, media, energies, 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 ###

• Creation of concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creation of qualification/validation plans/reports for all phases according to the Roche quality system
• Execution of qualifications/validations in all phases according to the Roche quality system
• Assessment of technical changes to equipment regarding the impact on the qualified state and independent processing of requalification activities
• GMP-compliant documentation of the work performed and summary of deviations occurred
• Development of proposed solutions for the deviations occurred
• Training in electronic qualification and validation software

Must-Haves ###

• Degree in a natural science/engineering course of study or relevant professional experience.
• Min. 3 years of professional experience and sound 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 area with in-depth understanding of quality systems and the lean implementation of GMP requirements
• Good knowledge of the topic -Data Integrity-
• Very good German language skills in speaking and writing, 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 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 up-to-date tools in an innovative working environment
• Start with professional onboarding and a sound introduction to your new role during the Welcome Days
• Benefit from financial support for your professional continuing education plans
• Enjoy a selection of high-quality food in modern company restaurants
• Use attractive fitness and swimming pool offers or the gaming room as a creative retreat
• As part of a sustainable mobility concept, on-site parking facilities are available to you (according to internal guidelines)
• Use unbeatable, year-round discounts at well-known 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 to us online today.

We look forward to meeting you!