Qualification Engineer (Drug Substance)

Randstad Switzerland; Basel; Hybrid; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Randstad Switzerland is seeking a Qualification Engineer in Drug Substance for Basel, with 1 year duration. The role requires hands-on equipment qualification and CSV work within GMP environments, including process systems and utilities.

English and German language skills are essential, and a degree in natural sciences or engineering is expected. The ideal candidate will manage QPPs, VMPs, and qualification reports, perform end-to-end qualifications, and support regulatory inspections.

Qualifikationen

• Experience in qualification/validation of equipment and CSV
• Hands-on experience qualifying/validating equipment and systems
• Strong understanding of GMP principles and data integrity

Aufgaben

• Create Qualification Project Plans (QPPs), and Validation Master Plans (VMPs)
• Author qualification/validation plans and reports across all phases
• Execute qualifications/validations per Quality System
• Evaluate changes affecting qualified status and manage requalification
• Document GMP-compliant tasks and summarize any deviations
• Develop proposed solutions for deviations and assist with electronic QA tools

Kenntnisse

GMP experience

Data Integrity

German language

English language

Ausbildung

Degree in natural sciences/engineering

Tools

CSV software

Jobbeschreibung

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: 01.10.2026
• Duration: 1 year with likely extension
• Work Location: Basel
• 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

Application Submission Deadline: 21.08.2026