Qualification Engineer (Drug Substance)

Randstad Switzerland; Basel; Hybrid; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Randstad Switzerland in Basel seeks a specialist in Pharma Engineering with equipment qualification and CSV expertise to join a pharma manufacturing team. The role starts ASAP for 1 year with potential extension, in Basel with 3 days onsite and possible home office.

You will design QPPs, write qualification/validation plans, perform qualifications across all phases, and manage requalification while ensuring GMP compliance. Fluent German and good English are required.

Qualifikationen

• Degree in natural sciences or engineering or equivalent work experience.
• Min 3 years of professional experience in qualification/validation (CSV).
• Hands-on experience qualifying/validating equipment, systems, cleanrooms, and utilities.
• GMP experience and lean GMP implementation.
• Data Integrity knowledge.
• Very good written and spoken German; good English skills.

Aufgaben

• Create Qualification Projects Plans (QPPs) and Validation Master Plans (VMPs).
• Author qualification and validation plans and reports according to the Quality System.
• Execute qualifications/validations across all phases according to the Quality System.
• Evaluate changes to equipment regarding impact on qualified status and manage requalification.
• GMP-compliant documentation of completed tasks and summarize deviations.
• Develop solutions for deviations identified.
• Onboard and work with electronic qualification/validation software.

Kenntnisse

CSV qualification

Equipment qualification

GMP experience

Data integrity

German language

English language

Ausbildung

Natural sciences/engineering degree

Tools

CSV software

Qualification software

Validation software

Jobbeschreibung

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a

General Information:

• Start Date: asap
• 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: 28.09.2026