Senior Validation Engineer

Bayside Hotel Group; Melbourne; On-site; AUD 180,000 - 220,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Validation leadership

Regulatory compliance

Project management

Stakeholder influence

Education

Postgraduate qualification

Tools

ISO 13485 knowledge

ISPE guidance

FDA guidance

Job description

Lead high-impact validation projects in a regulated medical device environment

Apply your expertise across HVAC, facilities, purified water and cleanrooms

Join a collaborative Operations team on a six-month contract

About the opportunity

We are seeking an experienced Senior Validation Engineer to support the strategic planning, execution and continuous improvement of qualification and validation activities across the organisation. Working within Operations, you will strengthen validation governance, improve process capability and help ensure practices meet regulatory expectations, internal quality standards and changing business needs.

What you’ll be doing:

Validation leadership

Support the Validation Manager in overseeing validation strategy across equipment, processes, packaging, and software.

Lead selected validation projects, ensuring the development of robust protocols, risk assessments, and validation reports.

Mentor engineers and technicians in validation best practices and validation lifecycle principles.

Quality and continuous improvement

Drive periodic validation reviews to keep activities current, compliant and aligned with process performance and regulatory expectations.

Identify opportunities to improve validation processes, documentation quality and lifecycle management practices.

Lead and support validation-related CAPA actions, ensuring timely, thorough and compliant closure.

Analyse process performance data to identify trends, inefficiencies, emerging risks and opportunities for improvement.

Audit and regulatory compliance

Participate in external audits conducted by regulatory authorities and notified bodies.

Perform gap assessments against regulatory standards, identify validation gaps, and collaborate with QA and process stakeholders to implement corrective actions.

Ensure validation lifecycle activities conform to specifications, internal procedures, and applicable laws, regulations, and safety standards.

What you’ll bring:

A postgraduate qualification in science, biomedical science, biotechnology, engineering or a related discipline.

At least eight years’ relevant experience in medical device or biotechnology manufacturing regulated by ISO 13485 and the FDA.

Strong working knowledge of ISO 13485, ISPE guidance and applicable FDA guidance.

Hands-on experience in equipment and process qualification, software validation and test method validation.

Demonstrated experience with HVAC, facilities, purified water systems and cleanrooms.

Visual inspection validation experience will be highly regarded.

Experience participating in internal and external regulatory audits.

Project management capability and a proactive, results-focused approach.

Excellent written and verbal communication skills, with the ability to influence stakeholders.

Advanced proficiency in Microsoft Word, Excel and PowerPoint.

Strong attention to detail, sound problem-solving skills and the flexibility to work outside normal hours when required.