Greenfield CQV Engineer for Biotech/Pharma Lines

agap2 Switzerland; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

agap2 is seeking a GMP validation and equipment qualification expert to join a brand-new greenfield project in a biotech/pharma/medtech environment. You will define URS, lead VMP creation, and develop FAT/SAT/IQ/OQ/PQ protocols for new production lines and utilities, ensuring GMP-compliant startup.

You will collaborate with engineering, suppliers and operations to bring the entire site to operational excellence on site in Basel.

Qualifikationen

• GMP process validation experience required.
• Equipment qualification experience required.
• Strong knowledge of Good Manufacturing Practices.

Aufgaben

• Define technical expectations by developing URS and performing risk analyses (FMEA, FRA).
• Lead the creation and review of the Validation Master Plan (VMP) for equipment, utilities and facilities.
• Design, write, and optimize qualification and commissioning protocols (FAT/SAT/IQ/OQ/PQ) under GMP/MDR.
• Participate in FAT/SAT on-site to ensure equipment readiness and delivery.
• Execute IQ/OQ/PQ activities to qualify new systems and ensure GMP startup.
• Collaborate with engineering, suppliers and operations to bring a greenfield site to operational excellence.

Kenntnisse

URS development

GMP process validation

Equipment qualification

GMP knowledge

FAT/SAT/IQ/OQ/PQ protocols

Ausbildung

Biotechnology

Pharmaceutical sciences

Process engineering

PharmD with industrial focus

Tools

FAT/SAT/IQ/OQ/PQ

Jobbeschreibung

agap2 is seeking a GMP validation and equipment qualification expert to join a brand-new greenfield project in a biotech/pharma/medtech environment. You will define URS, lead VMP creation, and develop FAT/SAT/IQ/OQ/PQ protocols for new production lines and utilities, ensuring GMP-compliant startup.

You will collaborate with engineering, suppliers and operations to bring the entire site to operational excellence on site in Basel.