Qualification Engineer (Drug Substance)

Jobdescription

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Qualification Engineer in Drug Substance.

General Information:

• Start Date: asap
• Latest possible start date: 01.12.2026
• Duration: 1 year with the possibility of extension
• Work Location: Basel
• Workload: 80-100%
• Home Office: possible, (3 days in a week onsite presence is required)
• Department: Pharma Engineering Drug Substance Qualification
• Working Hours: Standard

About the job:

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

The working environment includes process systems, utilities, energy, HVAC—such as reactors, fermenters, centrifuges, purified water, steam, autoclaves, and cleanrooms—along with the corresponding control systems and distributed control systems (CSV).

The ideal candidate:

Has experience in qualifying production equipment and validating computer systems, and is well-versed in the practical implementation of GMP guidelines. They write changes and deviations impeccably and present them confidently alongside equipment qualification and CSV during regulatory authority inspections. Work and time management are self-organized and coordinated consensually with the team and clients.

Tasks & Responsibilities:

• Creating concepts, QPPs (Qualification Project Plans), and VMPs (Validation Master Plans)
• Authoring qualification/validation plans and reports for all phases according to the Quality System
• Executing qualifications/validations across all phases according to the Quality System
• Evaluating technical changes to equipment regarding their impact on qualified status and independently managing requalification activities
• GMP-compliant documentation of completed tasks and summarizing any deviations that occur
• Developing proposed solutions for identified deviations
• Onboarding/working with electronic qualification and validation software

Must-Haves:

• Degree in natural sciences/engineering or equivalent relevant work experience
• Min. 3 years of professional experience and sound expertise in the qualification process
• Practical hands-on experience qualifying/validating (CSV) various types of equipment, systems, cleanrooms, and utilities
• Multiple years of GMP experience with a deep understanding of quality systems and the lean implementation of GMP requirements
• Good knowledge of Data Integrity concepts
• Very good written and spoken German; good English skills

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

Application Submission Deadline: 28.09.2026