CQV Engineer: GMP Validation for Pharma & Biotech (On-site)

agap2 Switzerland; Bern; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Challenging projects

Career development

Local management support

Zusammenfassung

agap2 Switzerland is seeking a CQV Engineer to support GMP pharma/biotech projects on-site from installation to validation. You will work with major clients to ensure compliant, efficient commissioning and qualification processes.

Responsibilities include executing DQ/IQ/OQ/PQ, meeting milestones, supervising vendors, and producing validation documentation. Strong GMP knowledge and fluency in German or English are required.

Qualifikationen

• Bachelor's or Master's in Engineering, Pharmaceutical Sciences or related field.
• 3+ years CQV experience in GMP pharma/biotech.
• Strong knowledge of GMP and regulatory requirements.
• Fluent in German and/or English.

Aufgaben

• Execute and approve DQ, IQ, OQ, and PQ activities.
• Ensure CQV milestones and timelines are met.
• Supervise vendors and validate commissioning quality.
• Generate and review validation protocols, reports, and documentation.
• Track deviations, non-conformances, and CAPAs.
• Assess project risks and implement corrective actions.

Kenntnisse

CQV experience

GMP knowledge

German language

English language

Ausbildung

Bachelor's or Master's in Engineering, Pharmaceutical Sciences

Jobbeschreibung

agap2 Switzerland is seeking a CQV Engineer to support GMP pharma/biotech projects on-site from installation to validation. You will work with major clients to ensure compliant, efficient commissioning and qualification processes.

Responsibilities include executing DQ/IQ/OQ/PQ, meeting milestones, supervising vendors, and producing validation documentation. Strong GMP knowledge and fluency in German or English are required.