Validation Engineer

BioTalent; Oberwallis; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

BioTalent, a global biotechnology organisation, is seeking a QA Validation Specialist to support a major facility expansion. The role focuses on QA oversight of qualification and validation activities within a GMP-regulated environment.

You will manage QA oversight, review validation documentation, support change control, ensure facilities and systems remain compliant, and participate in audits and regulatory inspections.

Qualifikationen

• 2–6 years of Validation/Qualification experience.
• GMP pharmaceutical, biotech, biologics, or cell & gene experience.
• Strong knowledge of IQ, OQ, PQ, validation lifecycle, and change control.
• Experience reviewing SOPs, protocols, reports, deviations, CAPAs, and change controls.
• Knowledge of EU GMP and FDA regulations.

Aufgaben

• Manage QA oversight of qualification and validation programmes.
• Review and approve validation documentation.
• Support Change Control and validation lifecycle activities.
• Ensure facilities, equipment, and systems remain compliant and validated.
• Participate in audits and regulatory inspections.
• Support quality systems including deviations, CAPAs, and change management.

Kenntnisse

Validation experience

GMP knowledge

IQ/OQ/PQ

Change control

Documentation review

Jobbeschreibung

A global biotechnology manufacturing organisation is seeking a QA Validation Specialist to support a major facility expansion project. The role focuses on QA oversight of qualification and validation activities within a GMP-regulated environment.

Key Responsibilities

• Manage QA oversight of qualification and validation programmes.
• Review and approve validation documentation.
• Support Change Control and validation lifecycle activities.
• Ensure facilities, equipment, and systems remain compliant and validated.
• Participate in audits and regulatory inspections.
• Support quality systems including deviations, CAPAs, and change management.

Requirements

• 2–6 years of Validation/Qualification experience.
• GMP pharmaceutical, biotech, biologics, or cell & gene experience.
• Strong knowledge of IQ, OQ, PQ, validation lifecycle, and change control.
• Experience reviewing SOPs, protocols, reports, deviations, CAPAs, and change controls.
• Knowledge of EU GMP and FDA regulations.