Senior Validation Engineer — Medical Devices (6-Month Contract)

Bayside Hotel Group; Melbourne; Sur place; AUD 180 000 - 220 000; Plein temps

Résumé du poste

Bayside Hotel Group in Melbourne seeks a Senior Validation Engineer to lead GMP-compliant qualification and validation across equipment, processes, packaging and software. You will help strengthen validation governance, improve process performance and ensure adherence to ISO 13485 and FDA guidance.

Join our collaborative Operations team on a six-month contract to drive validation lifecycle activities, CAPA closures and regulatory audits, and mentor engineers in validation best practices and

Qualifications

• Postgraduate qualification in science or engineering.
• Eight years' experience in medical device manufacturing.
• Experience with ISO 13485 and FDA guidance.
• Hands-on equipment, process qualification, and software validation.
• HVAC, facilities, purified water, and cleanrooms validation experience.
• Auditing experience with regulators.

Responsabilités

• Lead validation projects and develop protocols and reports.
• Mentor engineers in validation lifecycle best practices.
• Drive periodic reviews to ensure compliance and performance.
• Support internal and external audits and corrective actions.
• Analyse performance data to identify risks and improvements.

Connaissances

Validation leadership

Regulatory compliance

Project management

Stakeholder influence

Formation

Postgraduate qualification

Outils

ISO 13485 knowledge

ISPE guidance

FDA guidance

Description du poste

Bayside Hotel Group in Melbourne seeks a Senior Validation Engineer to lead GMP-compliant qualification and validation across equipment, processes, packaging and software. You will help strengthen validation governance, improve process performance and ensure adherence to ISO 13485 and FDA guidance.

Join our collaborative Operations team on a six-month contract to drive validation lifecycle activities, CAPA closures and regulatory audits, and mentor engineers in validation best practices and