Drug Substance Qualification Engineer — GMP/CSV (Basel)

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

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.