CQV QA Engineer – Pharma/Biotech (GMP/FDA) – Switzerland

TechFirm Engineering; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Techfirm Engineering in Basel is seeking a QA / Qualification engineer to lead CQV activities for equipment, utilities and cleanrooms in pharma/biotech projects.

You will review URS, risk assessments, test plans, deviations and change controls, and ensure GMP/FDA compliance while collaborating with Engineering, Operations and vendors.

German language is mandatory; fluent English is a strong plus, and the role offers long-term engagement in a multicultural, Swiss-headquartered environment.

Qualifikationen

• Minimum 5 years of experience in CQV/Qualification/Process Engineering in pharma/biotech CAPEX projects.
• Strong knowledge of GMP, FDA regulations, ISPE Baseline Guides, GAMP 5.
• German mandatory; fluent English is a strong plus.
• Experience with clean utilities, aseptic manufacturing and cleanroom operations is a plus.
• Excellent technical writing, organizational and stakeholder management skills.

Aufgaben

• Lead Commissioning, Qualification & Validation (CQV) activities for equipment, utilities and cleanrooms.
• Review and approve CQV documentation including URS, risk assessments, test plans, deviations and change controls.
• Conduct risk analyses (FMEA) and support CAPA/non-conformity management.
• Collaborate with Engineering, Operations and vendors to qualify and validate new equipment/processes.
• Contribute to QMS, SOPs and training with hands-on involvement in cleanroom operations.

Kenntnisse

CQV

GMP compliance

FMEA risk analysis

Technical writing

Stakeholder management

German language

Project collaboration

Ausbildung

Master's degree in Science/Engineering

Jobbeschreibung

Techfirm Engineering in Basel is seeking a QA / Qualification engineer to lead CQV activities for equipment, utilities and cleanrooms in pharma/biotech projects.

You will review URS, risk assessments, test plans, deviations and change controls, and ensure GMP/FDA compliance while collaborating with Engineering, Operations and vendors.

German language is mandatory; fluent English is a strong plus, and the role offers long-term engagement in a multicultural, Swiss-headquartered environment.